Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01081262 |
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Recruitment Status :
Active, not recruiting
First Posted : March 5, 2010
Last Update Posted : August 22, 2017
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Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI)
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Brief Summary:
This randomized phase III trial studies carboplatin given together with paclitaxel with or without bevacizumab to see how well it works compared with oxaliplatin given together with capecitabine with or without bevacizumab as first-line therapy in treating patients with newly diagnosed stage II-IV, or recurrent (has come back) stage I epithelial ovarian or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. It is not yet known which regimen of combination chemotherapy given together with or without bevacizumab is more effective in treating epithelial ovarian cancer or fallopian tube cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Borderline Ovarian Mucinous Tumor Ovarian Mucinous Cystadenocarcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Stage IA Fallopian Tube Cancer Stage IA Ovarian Cancer Stage IB Fallopian Tube Cancer Stage IB Ovarian Cancer Stage IC Fallopian Tube Cancer Stage IC Ovarian Cancer Stage IIA Fallopian Tube Cancer Stage IIA Ovarian Cancer Stage IIB Fallopian Tube Cancer Stage IIB Ovarian Cancer Stage IIC Fallopian Tube Cancer Stage IIC Ovarian Cancer Stage IIIA Fallopian Tube Cancer Stage IIIA Ovarian Cancer Stage IIIB Fallopian Tube Cancer Stage IIIB Ovarian Cancer Stage IIIC Fallopian Tube Cancer Stage IIIC Ovarian Cancer Stage IV Fallopian Tube Cancer Stage IV Ovarian Cancer | Biological: Bevacizumab Drug: Capecitabine Drug: Carboplatin Other: Laboratory Biomarker Analysis Drug: Oxaliplatin Drug: Paclitaxel Other: Quality-of-Life Assessment | Phase 3 |
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PRIMARY OBJECTIVES:
I. To determine if capecitabine and oxaliplatin reduces the death rate compared to carboplatin and paclitaxel in women with mucinous adenocarcinoma of the ovary or fallopian tube.
II. To determine if bevacizumab reduces the death rate compared to no bevacizumab in women with mucinous adenocarcinoma of the ovary or fallopian tube.
SECONDARY OBJECTIVES:
I. To determine if capecitabine and oxaliplatin increases the duration of progression-free survival (PFS) compared to carboplatin and paclitaxel in women with mucinous adenocarcinoma of the ovary or fallopian tube.
II. To determine if bevacizumab increases the duration of PFS compared to no bevacizumab in women with mucinous adenocarcinoma of the ovary or fallopian tube.
III. To compare the response rates for capecitabine and oxaliplatin versus carboplatin and paclitaxel in patients with mucinous adenocarcinoma of the ovary or fallopian tube with measurable disease after initial tumor reductive surgery.
IV. To compare the response rates for bevacizumab versus no bevacizumab in patients with mucinous adenocarcinoma of the ovary or fallopian tube with measurable disease after initial tumor reductive surgery.
V. To determine the nature and degree of toxicity of capecitabine and oxaliplatin compared with that of carboplatin and paclitaxel in this cohort of patients.
VI. To determine the nature and degree of toxicity of bevacizumab in this cohort of patients.
VII. To compare capecitabine and oxaliplatin versus carboplatin and paclitaxel with respect to changes in patient reported neurotoxicity.
VIII. To determine the impact on quality of life (QOL, as measured by the Functional Assessment of Cancer Therapy-Ovarian [FACT-O] Trial Outcome Index [TOI]) following treatment with the above regimens.
TERTIARY OBJECTIVES:
I. To collect fixed and/or frozen tissue and whole blood for future research studies.
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
ARM I: Patients receive carboplatin intravenously (IV) over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine orally (PO) twice daily (BID) on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
ARM III: Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
ARM IV: Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.
After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 16 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A GCIG Intergroup Multicenter Phase III Trial of Open Label Carboplatin and Paclitaxel +/- NCI-Supplied Agent: Bevacizumab (NSC #704865) Compared With Oxaliplatin and Capecitabine +/- Bevacizumab as First Line Chemotherapy in Patients With Mucinous Epithelial Ovarian or Fallopian Tube Cancer (MEOC) |
| Actual Study Start Date : | October 12, 2010 |
| Actual Primary Completion Date : | February 25, 2015 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Ovarian cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm I (carboplatin and paclitaxel)
Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
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Drug: Carboplatin
Given IV Other: Laboratory Biomarker Analysis Correlative studies Drug: Paclitaxel Given IV Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment |
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Experimental: Arm II (oxaliplatin and capecitabine)
Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
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Drug: Capecitabine
Given PO Other: Laboratory Biomarker Analysis Correlative studies Drug: Oxaliplatin Given IV Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment |
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Experimental: Arm III (carboplatin, paclitaxel, bevacizumab)
Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
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Biological: Bevacizumab
Given IV Drug: Carboplatin Given IV Other: Laboratory Biomarker Analysis Correlative studies Drug: Paclitaxel Given IV Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment |
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Experimental: Arm IV (oxaliplatin, capecitabine, bevacizumab)
Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.
|
Biological: Bevacizumab
Given IV Drug: Capecitabine Given PO Other: Laboratory Biomarker Analysis Correlative studies Drug: Oxaliplatin Given IV Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment |
Primary Outcome Measures :
- Overall survival [ Time Frame: Up to 7 years ]Examined using Kaplan-Meier curves. The main effect size will be quantified by the hazard ratio and 95% confidence interval. Multivariate regression will also be used to examine whether there is an interaction between oxaliplatin + capecitabine and bevacizumab.
Secondary Outcome Measures :
- Incidence of adverse effects assessed by CTCAE version 4.0 [ Time Frame: Up to 7 years ]Toxicity grades will be tabulated showing the maximum toxicity grade experienced by each patient. The proportions of patients experiencing a maximum grade of 3 or above will be compared between the treatment groups.
- Progression-free survival [ Time Frame: Up to 7 years ]Examined using Kaplan-Meier curves. The main effect size will be quantified by the hazard ratio and 95% confidence interval. Multivariate regression will also be used to examine whether there is an interaction between oxaliplatin + capecitabine and bevacizumab.
- QOL scores assessed using FACT-O TOI and FACT-GOG/Neurotoxicity 4 [ Time Frame: Up to 60 months ]Analysis of the QOL data will use the observed scores at each time point, where available. For simplicity, the change from baseline to each of time points will be examined. However, the main analysis will be a repeated measures analysis (for example, based on a mixed model, Proc Mixed in SAS) used to simultaneously compare all QOL scores between the two treatment groups.
- Response rates assessed by RECIST 1.1 [ Time Frame: Up to 7 years ]The comparison of response rates (proportion of patients with complete and partial response, stable and progressive disease) between treatment groups, will use a chi-square test. The difference in response rates between the groups and the odds ratio (with corresponding 95% confidence intervals) will also be calculated.
Other Outcome Measures:
- Numbers and percentages of patients with mutations in the Kirsten rat sarcoma viral oncogene homolog (KRAS) oncogene [ Time Frame: Baseline ]Will be tabulated. Interactions between the mutational status of the KRAS oncogene and treatment will be examined.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with a histologic diagnosis of mucinous adenocarcinoma of the ovary or fallopian tube with either optimal (=< 1 cm residual disease) or suboptimal residual disease following initial surgery; patients may have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or no measurable disease
- All patients must have had appropriate surgery including appendectomy (unless patient has history of prior appendectomy) for ovarian or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage
- Patients must have stage II-IV disease (new or recurrent-chemonaïve; no brain metastasis) or recurrent stage I disease (chemonaïve)
- Newly diagnosed patients must begin protocol therapy within 10 weeks of primary debulking; for stage I recurrent patients (chemonaïve), they should begin protocol therapy within 14 days of randomization
- Patients must have a negative colonoscopy within 1 year of enrolling in the study
- Absolute neutrophil count (ANC) >= 1,500/mcl
- White blood cell (WBC) count >= 3,000/mcl
- Platelets >= 100,000/mcl
- Hemoglobin (Hgb) >= 10 g/dl (can be post transfusion)
- Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN) OR creatinine clearance > 50 cc/min
- Bilirubin =< 1.5 x ULN
- Serum glutamic oxaloacetic transaminase (SGOT) =< to 2.5 x ULN
- Alkaline phosphatase =< to 2.5 x ULN
- Neuropathy (sensory and motor) =< Common Terminology Criteria for Adverse Events (CTCAE) grade 1
- Urine dipstick for proteinuria < 2+; if urine dipstick is >= 2+, 24 hour urine must demonstrate =< 1 g protein in 24 hours OR patients must have a urine protein-to-creatinine ratio (UPCR) < 1.0 mg/dL
- Prothrombin time (PT) =< 1.5 x ULN
- Activated prothrombin time (APTT) =< 1.5 x ULN
- Patients of childbearing potential must agree to practice an effective form of birth control during study treatment and for six months after completion of treatment
- Patients who have met the pre-entry requirements
- Patients must have signed an approved informed consent and authorization permitting release of personal health information
- Patients with Gynecologic Oncology Group (GOG) performance grade of 0, 1 or 2
- Patients with life expectancy > 3 months
Exclusion Criteria:
- Patients with known colon cancer or history of colon cancer
- Patients with primary peritoneal carcinoma
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last 5 years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
- Patients who have received chemotherapy, radiotherapy or any investigational treatment for a gynecologic cancer (does include breast cancer) or colorectal cancer prior to enrollment
- Patients with a major surgical procedure anticipated during the course of the study; this includes but is not limited to: abdominal surgery (laparotomy or laparoscopy) such as colostomy or enterostomy reversal, interval or secondary cytoreductive surgery, or second look surgery; please consult with the study chair prior to patient entry for any questions related to the classification of surgical procedures
- Patients may have minor surgical procedures (i.e., mediport insertion) fine needle aspiration or core biopsies as long as it is performed > 7 days prior to the first date of bevacizumab therapy and there is no evidence of wound disruption or impaired healing
- Patients with surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab (allowing for fact that bevacizumab can be omitted from first cycle of chemotherapy)
- Patients with a history of abdominal fistula or perforation within the past 12 months
- Patients with a current, serious, non-healing wound, ulcer, or bone fracture; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations
- Patients with known hypersensitivity to Chinese hamster cell products or other recombinant human or humanized antibodies
- Patients with mixed epithelial ovarian cancer histology
- Patients with tumors of low malignant potential
- History or evidence of upon physical examination of central nervous system (CNS) disease, including history of primary brain tumor or any history of brain metastases, or seizures not controlled with standard medical therapy
- Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 100 mm Hg; patients with a history of hypertension are permitted
- Myocardial infarction or unstable angina within 12 months of the first date of bevacizumab therapy
- New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication; women who have received prior treatment with anthracycline (including doxorubicin and/or liposomal doxorubicin) and have an ejection fraction < 50% will be excluded from the study
- Grade 1, category 2 or greater, peripheral vascular disease; patient cannot have anything worse than mild, symptomatic claudication with exercise
- History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of bevacizumab therapy
- History of pulmonary embolism or deep vein thrombosis in the past 6 months
- Previous history of malabsorption or other conditions preventing oral treatment
- Patients who are pregnant or nursing
- Patients with acute hepatitis or active infection that requires parenteral antibiotics
- Patients with active bleeding or pathologic conditions that carry a high risk of bleeding such as a known bleeding disorder, coagulopathy or tumor involving the major vessels
- Patients taking warfarin
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081262
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Locations
| United States, Alabama | |
| University of Alabama at Birmingham Cancer Center | |
| Birmingham, Alabama, United States, 35233 | |
| University of South Alabama Mitchell Cancer Institute | |
| Mobile, Alabama, United States, 36688 | |
| United States, Arizona | |
| Saint Joseph's Hospital and Medical Center | |
| Phoenix, Arizona, United States, 85013 | |
| United States, Arkansas | |
| Fowler Family Center for Cancer Care | |
| Jonesboro, Arkansas, United States, 72401 | |
| United States, California | |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | |
| Burbank, California, United States, 91505 | |
| East Bay Radiation Oncology Center | |
| Castro Valley, California, United States, 94546 | |
| Valley Medical Oncology Consultants-Castro Valley | |
| Castro Valley, California, United States, 94546 | |
| Bay Area Breast Surgeons Inc | |
| Emeryville, California, United States, 94608 | |
| Epic Care Partners in Cancer Care | |
| Emeryville, California, United States, 94608 | |
| Valley Medical Oncology Consultants-Fremont | |
| Fremont, California, United States, 94538 | |
| Los Angeles County-USC Medical Center | |
| Los Angeles, California, United States, 90033 | |
| USC / Norris Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90033 | |
| Contra Costa Regional Medical Center | |
| Martinez, California, United States, 94553-3156 | |
| El Camino Hospital | |
| Mountain View, California, United States, 94040 | |
| Highland General Hospital | |
| Oakland, California, United States, 94602 | |
| Alta Bates Summit Medical Center - Summit Campus | |
| Oakland, California, United States, 94609 | |
| Bay Area Tumor Institute | |
| Oakland, California, United States, 94609 | |
| Hematology and Oncology Associates-Oakland | |
| Oakland, California, United States, 94609 | |
| Tom K Lee Inc | |
| Oakland, California, United States, 94609 | |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | |
| Orange, California, United States, 92868 | |
| Doctors Medical Center- JC Robinson Regional Cancer Center | |
| San Pablo, California, United States, 94806 | |
| Olive View-University of California Los Angeles Medical Center | |
| Sylmar, California, United States, 91342 | |
| United States, Colorado | |
| The Medical Center of Aurora | |
| Aurora, Colorado, United States, 80012 | |
| University of Colorado Cancer Center - Anschutz Cancer Pavilion | |
| Aurora, Colorado, United States, 80045 | |
| Boulder Community Hospital | |
| Boulder, Colorado, United States, 80301 | |
| Penrose-Saint Francis Healthcare | |
| Colorado Springs, Colorado, United States, 80907 | |
| Porter Adventist Hospital | |
| Denver, Colorado, United States, 80210 | |
| Presbyterian - Saint Lukes Medical Center - Health One | |
| Denver, Colorado, United States, 80218 | |
| SCL Health Saint Joseph Hospital | |
| Denver, Colorado, United States, 80218 | |
| Rose Medical Center | |
| Denver, Colorado, United States, 80220 | |
| Colorado Cancer Research Program NCORP | |
| Denver, Colorado, United States, 80222 | |
| Swedish Medical Center | |
| Englewood, Colorado, United States, 80113 | |
| Saint Mary's Hospital and Regional Medical Center | |
| Grand Junction, Colorado, United States, 81501 | |
| North Colorado Medical Center | |
| Greeley, Colorado, United States, 80631 | |
| Saint Anthony Hospital | |
| Lakewood, Colorado, United States, 80228 | |
| Littleton Adventist Hospital | |
| Littleton, Colorado, United States, 80122 | |
| Sky Ridge Medical Center | |
| Lone Tree, Colorado, United States, 80124 | |
| Longmont United Hospital | |
| Longmont, Colorado, United States, 80501 | |
| McKee Medical Center | |
| Loveland, Colorado, United States, 80539 | |
| Parker Adventist Hospital | |
| Parker, Colorado, United States, 80138 | |
| Saint Mary Corwin Medical Center | |
| Pueblo, Colorado, United States, 81004 | |
| North Suburban Medical Center | |
| Thornton, Colorado, United States, 80229 | |
| SCL Health Lutheran Medical Center | |
| Wheat Ridge, Colorado, United States, 80033 | |
| United States, Connecticut | |
| Hartford Hospital | |
| Hartford, Connecticut, United States, 06102 | |
| The Hospital of Central Connecticut | |
| New Britain, Connecticut, United States, 06050 | |
| United States, Delaware | |
| Beebe Medical Center | |
| Lewes, Delaware, United States, 19958 | |
| Christiana Care Health System-Christiana Hospital | |
| Newark, Delaware, United States, 19718 | |
| United States, Florida | |
| Florida Hospital Orlando | |
| Orlando, Florida, United States, 32803 | |
| United States, Georgia | |
| Augusta University Medical Center | |
| Augusta, Georgia, United States, 30912 | |
| John B Amos Cancer Center | |
| Columbus, Georgia, United States, 31904 | |
| Northeast Georgia Medical Center-Gainesville | |
| Gainesville, Georgia, United States, 30501 | |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | |
| Savannah, Georgia, United States, 31405 | |
| United States, Hawaii | |
| Queen's Medical Center | |
| Honolulu, Hawaii, United States, 96813 | |
| University of Hawaii Cancer Center | |
| Honolulu, Hawaii, United States, 96813 | |
| Kapiolani Medical Center for Women and Children | |
| Honolulu, Hawaii, United States, 96826 | |
| United States, Illinois | |
| Saint Joseph Medical Center | |
| Bloomington, Illinois, United States, 61701 | |
| Illinois CancerCare-Bloomington | |
| Bloomington, Illinois, United States, 61704 | |
| Graham Hospital Association | |
| Canton, Illinois, United States, 61520 | |
| Illinois CancerCare-Canton | |
| Canton, Illinois, United States, 61520 | |
| Illinois CancerCare-Carthage | |
| Carthage, Illinois, United States, 62321 | |
| Memorial Hospital | |
| Carthage, Illinois, United States, 62321 | |
| University of Chicago Comprehensive Cancer Center | |
| Chicago, Illinois, United States, 60637 | |
| Heartland Cancer Research NCORP | |
| Decatur, Illinois, United States, 62526 | |
| Eureka Hospital | |
| Eureka, Illinois, United States, 61530 | |
| Illinois CancerCare-Eureka | |
| Eureka, Illinois, United States, 61530 | |
| Illinois CancerCare-Galesburg | |
| Galesburg, Illinois, United States, 61401 | |
| Illinois CancerCare-Havana | |
| Havana, Illinois, United States, 62644 | |
| Mason District Hospital | |
| Havana, Illinois, United States, 62644 | |
| Sudarshan K Sharma MD Limted-Gynecologic Oncology | |
| Hinsdale, Illinois, United States, 60521 | |
| Illinois CancerCare-Kewanee Clinic | |
| Kewanee, Illinois, United States, 61443 | |
| Illinois CancerCare-Macomb | |
| Macomb, Illinois, United States, 61455 | |
| Mcdonough District Hospital | |
| Macomb, Illinois, United States, 61455 | |
| Holy Family Medical Center | |
| Monmouth, Illinois, United States, 61462 | |
| Illinois CancerCare-Monmouth | |
| Monmouth, Illinois, United States, 61462 | |
| Bromenn Regional Medical Center | |
| Normal, Illinois, United States, 61761 | |
| Community Cancer Center Foundation | |
| Normal, Illinois, United States, 61761 | |
| Illinois CancerCare-Community Cancer Center | |
| Normal, Illinois, United States, 61761 | |
| Illinois CancerCare-Ottawa Clinic | |
| Ottawa, Illinois, United States, 61350 | |
| Ottawa Regional Hospital and Healthcare Center | |
| Ottawa, Illinois, United States, 61350 | |
| Illinois CancerCare-Pekin | |
| Pekin, Illinois, United States, 61554 | |
| OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center | |
| Pekin, Illinois, United States, 61554 | |
| Methodist Medical Center of Illinois | |
| Peoria, Illinois, United States, 61603 | |
| Proctor Hospital | |
| Peoria, Illinois, United States, 61614 | |
| Illinois CancerCare-Peoria | |
| Peoria, Illinois, United States, 61615 | |
| OSF Saint Francis Medical Center | |
| Peoria, Illinois, United States, 61637 | |
| Illinois CancerCare-Peru | |
| Peru, Illinois, United States, 61354 | |
| Illinois Valley Hospital | |
| Peru, Illinois, United States, 61354 | |
| Illinois CancerCare-Princeton | |
| Princeton, Illinois, United States, 61356 | |
| Perry Memorial Hospital | |
| Princeton, Illinois, United States, 61356 | |
| Illinois CancerCare-Spring Valley | |
| Spring Valley, Illinois, United States, 61362 | |
| United States, Indiana | |
| Elkhart Clinic | |
| Elkhart, Indiana, United States, 46514-2098 | |
| Michiana Hematology Oncology PC-Elkhart | |
| Elkhart, Indiana, United States, 46514 | |
| Elkhart General Hospital | |
| Elkhart, Indiana, United States, 46515 | |
| Indiana University/Melvin and Bren Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| Saint Vincent Hospital and Health Care Center | |
| Indianapolis, Indiana, United States, 46260 | |
| Community Howard Regional Health | |
| Kokomo, Indiana, United States, 46904 | |
| IU Health La Porte Hospital | |
| La Porte, Indiana, United States, 46350 | |
| Cancer Care Partners LLC | |
| Mishawaka, Indiana, United States, 46545 | |
| Michiana Hematology Oncology PC-Mishawaka | |
| Mishawaka, Indiana, United States, 46545 | |
| Saint Joseph Regional Medical Center-Mishawaka | |
| Mishawaka, Indiana, United States, 46545 | |
| Michiana Hematology Oncology PC-Plymouth | |
| Plymouth, Indiana, United States, 46563 | |
| Memorial Hospital of South Bend | |
| South Bend, Indiana, United States, 46601 | |
| Michiana Hematology Oncology PC-South Bend | |
| South Bend, Indiana, United States, 46601 | |
| South Bend Clinic | |
| South Bend, Indiana, United States, 46617 | |
| Northern Indiana Cancer Research Consortium | |
| South Bend, Indiana, United States, 46628 | |
| Michiana Hematology Oncology PC-Westville | |
| Westville, Indiana, United States, 46391 | |
| United States, Iowa | |
| Medical Oncology and Hematology Associates-West Des Moines | |
| Clive, Iowa, United States, 50325 | |
| Mercy Cancer Center-West Lakes | |
| Clive, Iowa, United States, 50325 | |
| Iowa Methodist Medical Center | |
| Des Moines, Iowa, United States, 50309 | |
| Iowa-Wide Oncology Research Coalition NCORP | |
| Des Moines, Iowa, United States, 50309 | |
| Medical Oncology and Hematology Associates-Des Moines | |
| Des Moines, Iowa, United States, 50309 | |
| Medical Oncology and Hematology Associates-Laurel | |
| Des Moines, Iowa, United States, 50314 | |
| Mercy Medical Center - Des Moines | |
| Des Moines, Iowa, United States, 50314 | |
| Iowa Lutheran Hospital | |
| Des Moines, Iowa, United States, 50316 | |
| Siouxland Regional Cancer Center | |
| Sioux City, Iowa, United States, 51101 | |
| Mercy Medical Center-Sioux City | |
| Sioux City, Iowa, United States, 51104 | |
| Saint Luke's Regional Medical Center | |
| Sioux City, Iowa, United States, 51104 | |
| Methodist West Hospital | |
| West Des Moines, Iowa, United States, 50266-7700 | |
| Mercy Medical Center-West Lakes | |
| West Des Moines, Iowa, United States, 50266 | |
| United States, Kentucky | |
| Saint Elizabeth Medical Center South | |
| Edgewood, Kentucky, United States, 41017 | |
| University of Kentucky/Markey Cancer Center | |
| Lexington, Kentucky, United States, 40536 | |
| Pikeville Medical Center | |
| Pikeville, Kentucky, United States, 41501 | |
| United States, Louisiana | |
| Cancer Center of Acadiana | |
| Lafayette, Louisiana, United States, 70503 | |
| Ochsner Medical Center Jefferson | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Maryland | |
| Greater Baltimore Medical Center | |
| Baltimore, Maryland, United States, 21204 | |
| Walter Reed National Military Medical Center | |
| Bethesda, Maryland, United States, 20889-5600 | |
| Union Hospital of Cecil County | |
| Elkton, Maryland, United States, 21921 | |
| United States, Massachusetts | |
| Baystate Medical Center | |
| Springfield, Massachusetts, United States, 01199 | |
| United States, Michigan | |
| Green Bay Oncology - Escanaba | |
| Escanaba, Michigan, United States, 49829 | |
| Green Bay Oncology - Iron Mountain | |
| Iron Mountain, Michigan, United States, 49801 | |
| Borgess Medical Center | |
| Kalamazoo, Michigan, United States, 49001 | |
| Bronson Methodist Hospital | |
| Kalamazoo, Michigan, United States, 49007 | |
| West Michigan Cancer Center | |
| Kalamazoo, Michigan, United States, 49007 | |
| Lakeland Community Hospital | |
| Niles, Michigan, United States, 49120 | |
| Lakeland Hospital | |
| Saint Joseph, Michigan, United States, 49085 | |
| Marie Yeager Cancer Center | |
| Saint Joseph, Michigan, United States, 49085 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| Southeast Cancer Center | |
| Cape Girardeau, Missouri, United States, 63703 | |
| Capital Region Medical Center-Goldschmidt Cancer Center | |
| Jefferson City, Missouri, United States, 65109 | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| Missouri Baptist Medical Center | |
| Saint Louis, Missouri, United States, 63131 | |
| United States, Montana | |
| Billings Clinic Cancer Center | |
| Billings, Montana, United States, 59101 | |
| Saint Vincent Healthcare | |
| Billings, Montana, United States, 59101 | |
| Montana Cancer Consortium NCORP | |
| Billings, Montana, United States, 59102 | |
| Saint Vincent Frontier Cancer Center | |
| Billings, Montana, United States, 59102 | |
| Bozeman Deaconess Hospital | |
| Bozeman, Montana, United States, 59715 | |
| Saint James Community Hospital and Cancer Treatment Center | |
| Butte, Montana, United States, 59701 | |
| Benefis Healthcare- Sletten Cancer Institute | |
| Great Falls, Montana, United States, 59405 | |
| Big Sky Oncology | |
| Great Falls, Montana, United States, 59405 | |
| Great Falls Clinic | |
| Great Falls, Montana, United States, 59405 | |
| Northern Montana Hospital | |
| Havre, Montana, United States, 59501 | |
| Saint Peter's Community Hospital | |
| Helena, Montana, United States, 59601 | |
| Glacier Oncology PLLC | |
| Kalispell, Montana, United States, 59901 | |
| Kalispell Medical Oncology | |
| Kalispell, Montana, United States, 59901 | |
| Kalispell Regional Medical Center | |
| Kalispell, Montana, United States, 59901 | |
| Montana Cancer Specialists | |
| Missoula, Montana, United States, 59802 | |
| Saint Patrick Hospital - Community Hospital | |
| Missoula, Montana, United States, 59802 | |
| United States, Nebraska | |
| Nebraska Methodist Hospital | |
| Omaha, Nebraska, United States, 68114 | |
| United States, Nevada | |
| Women's Cancer Center of Nevada | |
| Las Vegas, Nevada, United States, 89169 | |
| United States, New Jersey | |
| Cooper Hospital University Medical Center | |
| Camden, New Jersey, United States, 08103 | |
| Virtua Memorial | |
| Mount Holly, New Jersey, United States, 08060 | |
| Virtua Voorhees | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New Mexico | |
| University of New Mexico Cancer Center | |
| Albuquerque, New Mexico, United States, 87102 | |
| Southwest Gynecologic Oncology Associates Inc | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, New York | |
| Stony Brook University Medical Center | |
| Stony Brook, New York, United States, 11794 | |
| State University of New York Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| UNC Lineberger Comprehensive Cancer Center | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Wayne Memorial Hospital | |
| Goldsboro, North Carolina, United States, 27534 | |
| Park Ridge Hospital Breast Health Center | |
| Hendersonville, North Carolina, United States, 28792 | |
| Southeast Clinical Oncology Research (SCOR) Consortium NCORP | |
| Winston-Salem, North Carolina, United States, 27104 | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, North Dakota | |
| Mid Dakota Clinic | |
| Bismarck, North Dakota, United States, 58501 | |
| Saint Alexius Medical Center | |
| Bismarck, North Dakota, United States, 58501 | |
| United States, Ohio | |
| Summa Akron City Hospital/Cooper Cancer Center | |
| Akron, Ohio, United States, 44304 | |
| Mary Rutan Hospital | |
| Bellefontaine, Ohio, United States, 43311 | |
| Aultman Health Foundation | |
| Canton, Ohio, United States, 44710 | |
| Adena Regional Medical Center | |
| Chillicothe, Ohio, United States, 45601 | |
| University of Cincinnati/Barrett Cancer Center | |
| Cincinnati, Ohio, United States, 45219 | |
| Good Samaritan Hospital - Cincinnati | |
| Cincinnati, Ohio, United States, 45220 | |
| Bethesda North Hospital | |
| Cincinnati, Ohio, United States, 45242 | |
| Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106 | |
| MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| Cleveland Clinic Cancer Center/Fairview Hospital | |
| Cleveland, Ohio, United States, 44111 | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| Ohio State University Comprehensive Cancer Center | |
| Columbus, Ohio, United States, 43210 | |
| Mount Carmel East Hospital | |
| Columbus, Ohio, United States, 43213 | |
| Riverside Methodist Hospital | |
| Columbus, Ohio, United States, 43214 | |
| Columbus NCI Community Oncology Research Program | |
| Columbus, Ohio, United States, 43215 | |
| Grant Medical Center | |
| Columbus, Ohio, United States, 43215 | |
| The Mark H Zangmeister Center | |
| Columbus, Ohio, United States, 43219 | |
| Mount Carmel Health Center West | |
| Columbus, Ohio, United States, 43222 | |
| Doctors Hospital | |
| Columbus, Ohio, United States, 43228 | |
| Grady Memorial Hospital | |
| Delaware, Ohio, United States, 43015 | |
| Kettering Medical Center | |
| Kettering, Ohio, United States, 45429 | |
| Fairfield Medical Center | |
| Lancaster, Ohio, United States, 43130 | |
| Marietta Memorial Hospital | |
| Marietta, Ohio, United States, 45750 | |
| Hillcrest Hospital Cancer Center | |
| Mayfield Heights, Ohio, United States, 44124 | |
| Lake University Ireland Cancer Center | |
| Mentor, Ohio, United States, 44060 | |
| Knox Community Hospital | |
| Mount Vernon, Ohio, United States, 43050 | |
| Licking Memorial Hospital | |
| Newark, Ohio, United States, 43055 | |
| Southern Ohio Medical Center | |
| Portsmouth, Ohio, United States, 45662 | |
| Springfield Regional Medical Center | |
| Springfield, Ohio, United States, 45505 | |
| Saint Ann's Hospital | |
| Westerville, Ohio, United States, 43081 | |
| Genesis Healthcare System Cancer Care Center | |
| Zanesville, Ohio, United States, 43701 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Oklahoma Cancer Specialists and Research Institute-Tulsa | |
| Tulsa, Oklahoma, United States, 74146 | |
| United States, Pennsylvania | |
| Abington Memorial Hospital | |
| Abington, Pennsylvania, United States, 19001 | |
| Saint Luke's University Hospital-Bethlehem Campus | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822 | |
| Geisinger Medical Center-Cancer Center Hazleton | |
| Hazleton, Pennsylvania, United States, 18201 | |
| University of Pittsburgh Cancer Institute (UPCI) | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Geisinger Medical Group | |
| State College, Pennsylvania, United States, 16801 | |
| Geisinger Wyoming Valley/Henry Cancer Center | |
| Wilkes-Barre, Pennsylvania, United States, 18711 | |
| United States, Rhode Island | |
| Women and Infants Hospital | |
| Providence, Rhode Island, United States, 02905 | |
| United States, South Carolina | |
| AnMed Health Cancer Center | |
| Anderson, South Carolina, United States, 29621 | |
| AnMed Health Hospital | |
| Anderson, South Carolina, United States, 29621 | |
| Saint Francis Hospital | |
| Greenville, South Carolina, United States, 29601 | |
| Spartanburg Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, South Dakota | |
| Sanford Cancer Center-Oncology Clinic | |
| Sioux Falls, South Dakota, United States, 57104 | |
| Sanford USD Medical Center - Sioux Falls | |
| Sioux Falls, South Dakota, United States, 57117-5134 | |
| United States, Tennessee | |
| University of Tennessee - Knoxville | |
| Knoxville, Tennessee, United States, 37920 | |
| United States, Texas | |
| Parkland Memorial Hospital | |
| Dallas, Texas, United States, 75235 | |
| UT Southwestern/Simmons Cancer Center-Dallas | |
| Dallas, Texas, United States, 75390 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0565 | |
| M D Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Memorial Hermann Texas Medical Center | |
| Houston, Texas, United States, 77030 | |
| The Methodist Hospital System | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Danville Regional Medical Center | |
| Danville, Virginia, United States, 24541 | |
| Hematology Oncology Associates of Fredericksburg Inc | |
| Fredericksburg, Virginia, United States, 22408 | |
| Lynchburg Hematology-Oncology Clinic | |
| Lynchburg, Virginia, United States, 24501 | |
| United States, Wisconsin | |
| Green Bay Oncology at Saint Vincent Hospital | |
| Green Bay, Wisconsin, United States, 54301-3526 | |
| Saint Vincent Hospital Cancer Center Green Bay | |
| Green Bay, Wisconsin, United States, 54301 | |
| Green Bay Oncology Limited at Saint Mary's Hospital | |
| Green Bay, Wisconsin, United States, 54303 | |
| Saint Vincent Hospital Cancer Center at Saint Mary's | |
| Green Bay, Wisconsin, United States, 54303 | |
| Gundersen Lutheran Medical Center | |
| La Crosse, Wisconsin, United States, 54601 | |
| Holy Family Memorial Hospital | |
| Manitowoc, Wisconsin, United States, 54221 | |
| Bay Area Medical Center | |
| Marinette, Wisconsin, United States, 54143 | |
| Aurora Saint Luke's Medical Center | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Froedtert and the Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Aurora Sinai Medical Center | |
| Milwaukee, Wisconsin, United States, 53233 | |
| Green Bay Oncology - Oconto Falls | |
| Oconto Falls, Wisconsin, United States, 54154 | |
| Vince Lombardi Cancer Clinic-Sheboygan | |
| Sheboygan, Wisconsin, United States, 53081 | |
| Green Bay Oncology - Sturgeon Bay | |
| Sturgeon Bay, Wisconsin, United States, 54235 | |
| Aurora Medical Center in Summit | |
| Summit, Wisconsin, United States, 53066 | |
| Aurora West Allis Medical Center | |
| West Allis, Wisconsin, United States, 53227 | |
| United States, Wyoming | |
| Rocky Mountain Oncology | |
| Casper, Wyoming, United States, 82609 | |
| Welch Cancer Center | |
| Sheridan, Wyoming, United States, 82801 | |
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | David Gershenson | NRG Oncology |
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01081262 History of Changes |
| Other Study ID Numbers: |
NCI-2011-02516 NCI-2011-02516 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000667089 GOG-0241 GOG-0241 ( Other Identifier: NRG Oncology ) GOG-0241 ( Other Identifier: CTEP ) U10CA180868 ( U.S. NIH Grant/Contract ) U10CA027469 ( U.S. NIH Grant/Contract ) |
| First Posted: | March 5, 2010 Key Record Dates |
| Last Update Posted: | August 22, 2017 |
| Last Verified: | August 2017 |
Additional relevant MeSH terms:
|
Carcinoma Ovarian Neoplasms Fallopian Tube Neoplasms Cystadenocarcinoma Cystadenocarcinoma, Mucinous Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms |
Endocrine System Diseases Gonadal Disorders Fallopian Tube Diseases Adenocarcinoma Neoplasms, Cystic, Mucinous, and Serous Paclitaxel Oxaliplatin Albumin-Bound Paclitaxel Bevacizumab Carboplatin Capecitabine Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents |