Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is most effective in treating ovarian epithelial cancer and peritoneal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have stage III or stage IV ovarian cancer or primary peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Primary Peritoneal Cavity Cancer |
Drug: carboplatin Drug: gemcitabine hydrochloride Drug: paclitaxel Drug: pegylated liposomal doxorubicin hydrochloride Drug: topotecan hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Phase III Randomized Trial Of Paclitaxel And Carboplatin Versus Triplet Or Sequential Doublet Combinations In Patients With Epithelial Ovarian Or Primary Peritoneal Carcinoma |
| Study Start Date: | January 2001 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Compare the efficacy of paclitaxel and carboplatin with or without gemcitabine, doxorubicin HCl liposome, or topotecan, in terms of overall and progression-free survival, in patients with stage III or IV ovarian epithelial or serous primary peritoneal carcinoma.
- Determine the response rate in patients with measurable disease treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Compare the complications in patients treated with these regimens.
- Determine the dose-intensity and cumulative dose delivery for these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified into 1 of 3 strata according to extent of residual disease and plans for interval cytoreductive surgery:
- Stratum A: Optimal (microscopic or macroscopic) residual disease without plans for surgery
- Stratum B: Suboptimal residual disease without plans for surgery
- Stratum C: Suboptimal residual disease with plans for surgery Patients are randomized to 1 of 5 treatment arms.
- Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment continues every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive chemotherapy as in arm I and gemcitabine IV over 30 minutes on days 1 and 8. Treatment continues as in arm I.
- Arm III: Patients receive chemotherapy as in arm I during courses 1-8 and doxorubicin HCl liposome IV over 1 hour on day 1 during courses 1, 3, 5, and 7. Treatment continues as in arm I.
- Arm IV: Patients receive topotecan IV over 30 minutes on days 1-3 and carboplatin IV over 30 minutes on day 3. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy.
- Arm V: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 8. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy.
Patients with initial unresectable or suboptimal residual disease (more than 1 cm) may undergo interval cytoreductive surgery between courses 4 and 5 of chemotherapy.
Patients are followed every 3 months for 2 years and then every 6 months.
PROJECTED ACCRUAL: Approximately 4,000-5,000 patients (800-1,000 per treatment arm) will be accrued for this study within 3.5-5 years.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed stage III or IV ovarian epithelial or serous primary peritoneal carcinoma
The following are ineligible:
- Germ cell tumors
- Sex cord-stromal tumors
- Carcinosarcomas
- Mixed Mullerian tumors or carcinosarcomas
- Metastatic carcinomas from other sites to the ovary
- Low malignant potential tumors, including micropapillary serous carcinomas
- Mucinous primary peritoneal carcinoma
- Prior ovarian low malignant potential tumor (borderline carcinoma) that was surgically resected with subsequent development of invasive adenocarcinoma allowed if no prior chemotherapy
- Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery
Prior breast cancer allowed provided the following are true:
- Disease-free for more than 5 years
- No prior cytotoxic chemotherapy for breast cancer
Prior or concurrent primary endometrial cancer allowed if the following conditions are met:
- Stage no greater than IB
- Less than 3 mm invasion without vascular or lymphatic invasion
- No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesions
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- GOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
- No acute hepatitis
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No unstable angina
- No myocardial infarction within the past 6 months
- No evidence of abnormal cardiac conduction (e.g., bundle branch block, heart block) unless stable for the past 6 months
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No greater than grade 1 sensory or motor neuropathy
- No active infection that requires antibiotics
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- No severe or ongoing gastrointestinal bleeding that requires blood product support
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
Prior chemotherapy for cancer involving the abdominal cavity or pelvis allowed provided the following are true:
- More than 3 years since prior therapy
- No evidence of recurrent disease
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to any portion of the abdominal cavity or pelvis
Prior radiotherapy for localized breast, head and neck, or skin cancer allowed provided the following are true:
- More than 3 years since prior therapy
- No evidence of recurrent disease
Surgery:
- See Disease Characteristics
- No more than 12 weeks since prior surgical resection
Contacts and Locations
Show 127 Study Locations| Study Chair: | Michael A. Bookman, MD | Fox Chase Cancer Center |
| Investigator: | William P. McGuire, MD | Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center |
| Study Chair: | Amy D. Tiersten, MD | Herbert Irving Comprehensive Cancer Center |
| Study Chair: | Helen Pearce, PhD | Medical Research Council |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00011986 History of Changes |
| Other Study ID Numbers: | CDR0000068467, GOG-0182, SWOG-G0182, MRC-ICON5, ECOG-G0182, ISRCTN41636183 |
| Study First Received: | March 3, 2001 |
| Last Updated: | June 26, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer primary peritoneal cavity cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal 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 Neoplasms by Histologic Type Doxorubicin Gemcitabine Carboplatin Paclitaxel Topotecan Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013