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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00951496 |
Purpose
RATIONALE: 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. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving bevacizumab together with intravenous chemotherapy is more effective than giving bevacizumab together with intraperitoneal chemotherapy in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
PURPOSE: This randomized phase III trial is studying bevacizumab and intravenous chemotherapy to see how well they work compared with bevacizumab and intraperitoneal chemotherapy in treating patients with stage II, stage III, or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer |
Biological: bevacizumab Drug: carboplatin Drug: cisplatin Drug: paclitaxel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III Clinical Trial of Bevacizumab With IV Versus IP Chemotherapy in Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma NCI-Supplied Agent(s): Bevacizumab (NSC #704865, IND #7921) |
| Estimated Enrollment: | 1500 |
| Study Start Date: | August 2009 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1 in courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone in courses 7-22 in the absence of disease progression or unacceptable toxicity.
|
Biological: bevacizumab
Given IV
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
|
|
Experimental: Arm II
Patients receive paclitaxel as in arm I and carboplatin intraperitoneally (IP) on day 1. Patients also receive bevacizumab as in arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in arm I.
|
Biological: bevacizumab
Given IV
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
|
|
Experimental: Arm III
Patients receive paclitaxel IV over 3 hours on day 1, cisplatin IP on day 2, and paclitaxel IP on day 8. Patients also receive bevacizumab as in arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in arm I.
|
Biological: bevacizumab
Given IV
Drug: cisplatin
Given IP
Drug: paclitaxel
Given IV
|
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (FIGO stage II vs stage III vs stage IV) and size of residual disease after initial staging/debulking surgery (no gross residual disease vs gross residual disease with lesion ≤ 1 cm vs any gross residual disease with lesion > 1 cm). Patients are randomized to 1 of 3 treatment arms.
Patients complete quality-of-life questionnaires at baseline and at weeks 9, 18, 36, 60, and 84.
Blood and tissue samples may be collected for further laboratory analysis.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma, including any of the following epithelial cell types*:
NOTE: **Patients with mucinous, low grade or clear cell disease are eligible unless there is a higher priority GOG trial open.
Prior or concurrent primary endometrial cancer allowed provided the primary origin of the invasive tumor is ovarian or peritoneal and all of the following criteria are met:
No borderline ovarian epithelial tumor ("tumors of low malignant potential") (e.g., stage IA or IB disease with low-grade lesions)
PATIENT CHARACTERISTICS:
PTT < 1.5 times ULN
No serious non-healing wound, ulcer, or bone fracture
No clinical symptoms or signs of gastrointestinal obstruction and/or those who require parenteral hydration and/or nutrition
No clinically significant cardiovascular disease, including any of the following:
Serious cardiac arrhythmia requiring medication
PRIOR CONCURRENT THERAPY:
No prior radiotherapy to any portion of the abdominal cavity or pelvis
No prior chemotherapy for any abdominal or pelvic tumor, including neoadjuvant chemotherapy for ovarian or primary peritoneal cancer
Concurrent ovarian estrogen (with or without progestin) replacement therapy for control of menopausal symptoms allowed provided the lowest effective dose(s) is (are) given
Contacts and Locations
Show 443 Study Locations| Study Chair: | Joan L. Walker, MD | Oklahoma University Cancer Institute |
More Information
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00951496 History of Changes |
| Other Study ID Numbers: | CDR0000650601, GOG-0252 |
| Study First Received: | August 1, 2009 |
| Last Updated: | March 1, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
ovarian clear cell cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian mixed epithelial carcinoma ovarian mucinous cystadenocarcinoma ovarian undifferentiated adenocarcinoma ovarian serous cystadenocarcinoma Brenner tumor stage IIA ovarian epithelial cancer stage IIB ovarian epithelial cancer stage IIC ovarian epithelial cancer stage IIIA ovarian epithelial cancer stage IIIB ovarian epithelial cancer stage IIIC ovarian epithelial cancer stage IV ovarian epithelial cancer |
stage IIA fallopian tube cancer stage IIB fallopian tube cancer stage IIC fallopian tube cancer stage IIIA fallopian tube cancer stage IIIB fallopian tube cancer stage IIIC fallopian tube cancer stage IV fallopian tube cancer stage IIA primary peritoneal cavity cancer stage IIB primary peritoneal cavity cancer stage IIC primary peritoneal cavity cancer stage IIIA primary peritoneal cavity cancer stage IIIB primary peritoneal cavity cancer stage IIIC primary peritoneal cavity cancer stage IV primary peritoneal cavity cancer |
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Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Neoplasms by Histologic Type Bevacizumab Cisplatin Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Tubulin Modulators |