Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine, With or Without Bevacizumab, as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II, Stage III, Stage IV, or Recurrent Stage I Epithelial Ovarian Cancer or Fallopian Tube Cancer
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Purpose
This randomized phase III trial is studying 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, stage III, stage IV, or recurrent stage I epithelial ovarian cancer 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, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. 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 | Intervention | Phase |
|---|---|---|
|
Ovarian Mucinous Cystadenocarcinoma Ovarian Mucinous Cystadenoma With Proliferating Activity Recurrent Fallopian Tube Cancer Recurrent Ovarian Epithelial Cancer Stage IA Fallopian Tube Cancer Stage IA Ovarian Epithelial Cancer Stage IB Fallopian Tube Cancer Stage IB Ovarian Epithelial Cancer Stage IC Fallopian Tube Cancer Stage IC Ovarian Epithelial Cancer Stage IIA Fallopian Tube Cancer Stage IIA Ovarian Epithelial Cancer Stage IIB Fallopian Tube Cancer Stage IIB Ovarian Epithelial Cancer Stage IIC Fallopian Tube Cancer Stage IIC Ovarian Epithelial Cancer Stage IIIA Fallopian Tube Cancer Stage IIIA Ovarian Epithelial Cancer Stage IIIB Fallopian Tube Cancer Stage IIIB Ovarian Epithelial Cancer Stage IIIC Fallopian Tube Cancer Stage IIIC Ovarian Epithelial Cancer Stage IV Fallopian Tube Cancer Stage IV Ovarian Epithelial Cancer |
Procedure: quality-of-life assessment Drug: carboplatin Drug: paclitaxel Drug: oxaliplatin Drug: capecitabine Biological: bevacizumab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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, IND #113912) Compared With Oxaliplatin and Capecitabine +/- Bevacizumab as First Line Chemotherapy in Patients With Mucinous Epithelial Ovarian Cancer or Fallopian Tube Cancer (MEOC) |
- Overall survival [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]Examined using Kaplan-Meier curves.
- Progression-free survival [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
- Response rates assessed by Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]Compared among treatment arms by chi-square test.
- Frequency and severity of adverse effects assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) [ Time Frame: Up to 7 years ] [ Designated as safety issue: Yes ]
- Quality of life assessed by FACT-TOI, FACT-GOG/NTX-4, and EQ-5D [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 332 |
| Study Start Date: | January 2010 |
| Estimated Primary Completion Date: | July 2020 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Drug: carboplatin
Given IV
Other Names:
Drug: paclitaxel
Given IV
Other Names:
|
|
Experimental: Arm II (oxaliplatin and capecitabine)
Patients receive oxaliplatin IV over 2-6 hours on day 1 and oral capecitabine twice a day on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Drug: oxaliplatin
Given IV
Other Names:
Drug: capecitabine
Given orally
Other Names:
|
|
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.
|
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Drug: carboplatin
Given IV
Other Names:
Drug: paclitaxel
Given IV
Other Names:
Biological: bevacizumab
Given IV
Other Names:
|
|
Experimental: Arm IV (oxaliplatin, capecitabine, bevacizumab)
Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.
|
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Drug: oxaliplatin
Given IV
Other Names:
Drug: capecitabine
Given orally
Other Names:
Biological: bevacizumab
Given IV
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically confirmed mucinous carcinoma of the ovary or fallopian tube
- Cytological (e.g., fine-needle aspiration) examination is inadequate for diagnosis
- No epithelial non-mucinous cell types
Meets 1 of the following staging criteria:
- FIGO stage II-IV disease
- Recurrent stage I disease (chemonaïve)
- Patients must have a negative colonoscopy within 1 year before study entry
- No primary peritoneal carcinoma
- No epithelial ovarian tumors of low malignant potential
- No known brain metastases
- ECOG performance status 0-2
- Life expectancy > 3 months
- WBC ≥ 3 x 10^9/L
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Hemoglobin ≥ 10 g/dL (may be post-transfusion)
- Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Serum transaminases ≤ 2.5 x ULN
- Serum creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 50 mL/min
- Urine dipstick for proteinuria < 2+ OR 24-hour urine protein ≤ 1 g
- INR ≤ 1.5 x ULN
- APTT ≤ 1.5 x ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Adequate neurological function (sensory and motor neuropathy ≤ grade 1)
- No prior or concurrent peripheral neuropathy
- No evidence of upper GI cancer (e.g., pancreatic cancer) on CT or MRI scan
- No history of another malignancy except carcinoma in situ of the cervix or basal cell carcinoma of the skin
- No medical or psychiatric conditions that compromise the patient's ability to give informed consent
- No clinically significant cardiac disease, symptomatic coronary artery disease, or congestive heart failure
- No peripheral vascular disease ≥ grade 3 (i.e., symptomatic and interfering with activities of daily living requiring repair or revision), cardiac arrhythmia, or myocardial infarction within the past 12 months
- No known hypersensitivity to bevacizumab and its excipients or to chemotherapy (including cremophor)
- No history of malabsorption or other conditions preventing oral treatment
- No nonhealing wound, ulcer, or bone fracture (patients with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection are eligible provided they undergo three weekly wound examinations)
- No history or evidence of thrombotic or hemorrhagic disorders
- No uncontrolled hypertension (sustained elevation of BP > 150/100 mmHg despite antihypertensive therapy)
- No significant traumatic injury within the past 4 weeks
- No cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
- No other concurrent uncontrolled medical conditions
- No prior chemotherapy
- No prior radiotherapy or investigational treatment for ovarian or rectal cancer
- No prior mouse CA125 antibody
At least 10 days since prior and no concurrent chronic use of aspirin (> 325 mg/day)
- Prophylactic low-dose aspirin (≤ 325 mg/day) in patients who are at risk of an arterial thromboembolic event allowed
At least 4 weeks since prior surgery or open biopsy and no planned surgery during the 58-week period from the start of study treatment
- No second-look surgery
Contacts and Locations
Show 234 Study Locations| Principal Investigator: | David Gershenson | Gynecologic Oncology Group |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01081262 History of Changes |
| Other Study ID Numbers: | NCI-2011-02516, GOG-0241, U10CA027469 |
| Study First Received: | March 4, 2010 |
| Last Updated: | February 5, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cystadenocarcinoma Cystadenoma Cystadenoma, Mucinous Ovarian Neoplasms Fallopian Tube Neoplasms Cystadenocarcinoma, Mucinous Neoplasms, Glandular and Epithelial Adenocarcinoma Carcinoma Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Adenoma 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 Antibodies Antibodies, Monoclonal Fluorouracil Oxaliplatin Capecitabine Bevacizumab Carboplatin |
ClinicalTrials.gov processed this record on May 21, 2013