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
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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, IND #7921) 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 |
- Progression-free survival measured by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: From study entry until disease progression, death or date of last contact, up to 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: From study entry to death, up to 5 years ] [ Designated as safety issue: No ]
- 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 Enrollment: | 2000 |
| Study Start Date: | September 2005 |
| Estimated Primary Completion Date: | January 2100 (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:
Drug: carboplatin
Given IV
Other Names:
|
|
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:
Drug: carboplatin
Given IV
Other Names:
Biological: bevacizumab
Given IV
Other Names:
|
|
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:
Drug: carboplatin
Given IV
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 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
Show 634 Study Locations| 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, U10CA027469, CDR0000455114, GOG-0218 |
| Study First Received: | December 6, 2005 |
| Last Updated: | September 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cystadenocarcinoma Cystadenocarcinoma, Mucinous Cystadenocarcinoma, Serous Adenocarcinoma Adenocarcinoma, Mucinous Brenner Tumor Carcinoma Peritoneal Neoplasms Fallopian Tube Neoplasms Carcinoma, Endometrioid Neoplasms, Glandular and Epithelial Ovarian Neoplasms Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous |
Neoplasms, Fibroepithelial Neoplasms, Fibrous Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Gonadal Disorders Endocrine System Diseases Abdominal Neoplasms Neoplasms by Site Digestive System Neoplasms Digestive System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013