Trial record 5 of 93 for:    cancer | butyrate

Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal Cancer, or Fallopian Tube Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00262847
First received: December 6, 2005
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

This randomized phase III trial is studying carboplatin, paclitaxel, and bevacizumab to see how well they work compared to carboplatin, paclitaxel, and placebo in treating patients with stage III or stage IV ovarian epithelial, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are more effective than carboplatin, paclitaxel, and placebo in treating ovarian epithelial or primary peritoneal cancer , or fallopian tube cancer.


Condition Intervention Phase
Brenner Tumor
Fallopian Tube Cancer
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mixed Epithelial Carcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Serous Cystadenocarcinoma
Ovarian Undifferentiated Adenocarcinoma
Primary Peritoneal Cavity Cancer
Stage III Ovarian Epithelial Cancer
Stage IV Ovarian Epithelial Cancer
Other: hydrocortisone/placebo
Drug: paclitaxel
Drug: carboplatin
Biological: bevacizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC # 704865) Followed by Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women With Newly Diagnosed, Previously Untreated, Suboptimal Advanced Stage Epithelial Ovarian, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: From study entry until first disease progression, death or date of last contact, up to 6 years ] [ Designated as safety issue: No ]
    Median progression-free survival (PFS). Onset of progression could be based on radiographic (RECIST) criteria or rising CA-125 (GCIG criteria).


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: From study entry to death or last contact, up to 6 years ] [ Designated as safety issue: No ]
    Median overall survival (OS)

  • Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) [ Time Frame: At baseline, 9, 18, 36, 60, and 84 weeks ] [ Designated as safety issue: No ]
    Estimated least squares means from a mixed module of Quality of Life (QOL) scores at each assessment point, adjusted for baseline score and patient's age. Note: The range of possible scores of the FACT-O TOI is 0 - 104 for all treatment groups and at all visits. A higher score indicates better QOL. Baseline mean scores are raw means.


Enrollment: 1873
Study Start Date: September 2005
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (placebo, paclitaxel, carboplatin)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Beginning in course 2, patients also receive placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses. Beginning in course 7, patients receive placebo alone IV over 30-90 minutes on day 1. Treatment with placebo repeats every 21 days for up to 22 courses in the absence of disease progression or unacceptable toxicity.
Other: hydrocortisone/placebo
Given IV
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Experimental: Arm II (placebo, paclitaxel, carboplatin, bevacizumab)
Patients receive paclitaxel and carboplatin as in arm I. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses. Beginning in course 7, patients receive placebo alone IV over 30-90 minutes on day 1. Treatment with placebo repeats every 21 days for up to 22 courses in the absence of disease progression or unacceptable toxicity.
Other: hydrocortisone/placebo
Given IV
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Biological: bevacizumab
Given IV
Other Names:
  • anti-VEGF humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • Avastin
  • rhuMAb VEGF
Experimental: Arm III (paclitaxel, carboplatin, bevacizumab)
Patients receive paclitaxel and carboplatin as in arm I. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses. Beginning in course 7, patients receive bevacizumab alone IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 22 courses in the absence of disease progression or unacceptable toxicity.
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Biological: bevacizumab
Given IV
Other Names:
  • anti-VEGF humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • Avastin
  • rhuMAb VEGF

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed ovarian epithelial, primary peritoneal*, or fallopian tube cancer

    • Stage III with any gross (macroscopic or palpable) residual disease OR stage IV disease
  • The following histologic epithelial cell types are allowed provided the histologic features of the tumor are compatible with a primary müllerian epithelial adenocarcinoma:

    • Serous adenocarcinoma
    • Endometrioid adenocarcinoma
    • Mucinous adenocarcinoma
    • Undifferentiated carcinoma
    • Clear cell adenocarcinoma
    • Mixed epithelial carcinoma
    • Transitional cell carcinoma
    • Malignant Brenner tumor
    • Adenocarcinoma not otherwise specified
  • No borderline ovarian epithelial tumor (formerly "tumors of low malignant potential")

    • Prior diagnosis of a borderline tumor that was surgically resected and an unrelated, new, invasive ovarian epithelial or primary peritoneal cancer that subsequently develops is allowed provided there was no prior chemotherapy for any ovarian tumor
  • No recurrent invasive ovarian epithelial cancer treated with surgery only (e.g., stage IA or IB low-grade epithelial ovarian or fallopian tube cancer)
  • No synchronous primary endometrial cancer or prior primary endometrial cancer unless all of the following criteria are met:

    • Stage ≤ IB
    • Superficial myometrial invasion without vascular or lymphatic invasion
    • No poorly differentiated subtypes (i.e., papillary serous, clear cell, or other FIGO grade 3 lesions)
  • Must have undergone surgery for ovarian epithelial, primary peritoneal, or fallopian tube cancer in the past 1-12 weeks AND have tissue available for histologic evaluation

    • Patients with stage III disease in which the largest maximal diameter of any residual tumor implant a the completion of initial surgery is ≤ 1 cm will be defined as "optimal" (all others will be defined as "suboptimal")
  • Measurable or nonmeasurable disease
  • No tumor involving active major vessels
  • No prior or concurrent CNS disease, including primary brain tumor or brain metastases
  • Performance status - GOG 0-2
  • Absolute neutrophil count ≥ 1,500/mm^3 without induction or support by granulocyte colony stimulating factors
  • Platelet count ≥ 100,000/mm^3
  • No active bleeding
  • No known bleeding disorder or coagulopathy
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • INR ≤ 1.5 (2-3 with stable-dose therapeutic warfarin for management of venous thrombosis including pulmonary thromboembolus)
  • PTT < 1.2 times ULN
  • No acute hepatitis
  • Creatinine ≤ 1.5 times ULN
  • Urine protein:creatinine ratio < 1.0
  • Urine protein < 1 g/24-hr urine collection
  • No New York Heart Association class II-IV congestive heart failure
  • No myocardial infarction or unstable angina within the past 6 months
  • No uncontrolled hypertension (i.e., blood pressure > 150/90 mm Hg)
  • No serious cardiac arrhythmia requiring medication except for patients with asymptomatic atrial fibrillation with a controlled ventricular rate
  • No other clinically significant cardiovascular disease
  • No clinically significant peripheral vascular disease ≥ grade 2
  • No history of cerebral vascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • No neuropathy (sensory and motor) > grade 1
  • No known hypersensitivity to Chinese hamster ovary cell products or recombinant human or humanized antibodies
  • No other malignancy within the past 5 years except nonmelanoma skin cancer
  • No active infection that requires parenteral antibiotics
  • No serious nonhealing wound, ulcer, or bone fracture
  • No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days

    • Granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are allowed
  • No other pathological condition that would confer a high risk of bleeding
  • No uncontrolled seizures
  • No significant traumatic injury within the past 4 weeks
  • No clinical symptoms or signs of gastrointestinal obstruction that require parenteral hydration and/or nutrition
  • No other medical history or condition that, in the opinion of the investigator, would preclude study participation
  • No prior targeted therapy for ovarian epithelial or peritoneal primary cancer, including, but not limited to, any of the following:

    • Vaccines
    • Antibodies
    • Tyrosine kinase inhibitors
  • No prior bevacizumab
  • No other prior antivascular endothelial growth factors (VEGF)
  • No other concurrent biologic therapy
  • No other concurrent cytotoxic or anticancer therapy
  • No prior chemotherapy for abdominal or pelvic tumor including neoadjuvant chemotherapy for their ovarian or primary peritoneal cancer
  • More than 3 years since prior adjuvant chemotherapy for localized breast cancer AND patient remains free of recurrent or metastatic disease
  • No other concurrent chemotherapy
  • Ovarian estrogen with or without progestin replacement therapy as indicated at the lowest effective dose(s) for control of menopausal symptoms at any time allowed

    • No progestins for management of anorexia while on study-directed therapy or prior to disease progression
  • No prior hormonal therapy for ovarian, peritoneal primary, or fallopian tube cancer
  • No concurrent hormonal therapy
  • More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin AND patient remains free of recurrent or metastatic disease
  • No prior radiotherapy to the abdominal cavity or pelvis
  • No concurrent radiotherapy
  • No concurrent amifostine or other protective reagents
  • At least 4 weeks since prior major surgical procedure or open biopsy
  • At least 1 week since prior core biopsy
  • No concurrent major surgery including abdominal surgery (laparotomy or laparoscopy) prior to disease progression (e.g., colostomy or enterostomy reversal, interval or secondary cytoreductive surgery, or second look surgery
  • No prior cancer therapy that would preclude study treatment
  • No concurrent consolidation or maintenance therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262847

  Show 634 Study Locations
Sponsors and Collaborators
Investigators
Principal Investigator: Robert Burger Gynecologic Oncology Group
  More Information

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00262847     History of Changes
Other Study ID Numbers: NCI-2009-00590, NCI-2009-00590, CDR0000455114, GOG-0218, GOG-0218, U10CA027469
Study First Received: December 6, 2005
Results First Received: July 9, 2013
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Brenner Tumor
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Endometrial Neoplasms
Uterine Neoplasms
Endocrine Gland Neoplasms
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone-17-butyrate
Adenocarcinoma
Carcinoma
Cystadenocarcinoma
Carcinoma, Endometrioid
Cystadenocarcinoma, Mucinous
Cystadenocarcinoma, Serous
Ovarian Diseases
Adnexal Diseases

ClinicalTrials.gov processed this record on August 27, 2014