Ovarian Cancer Clinical Trial

Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Summary

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. 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.

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Full Description

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 surgeryPatients 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed stage III or IV ovarian epithelial or serous primaryperitoneal carcinoma

The following are ineligible:

Germ cell tumors
Sex cord-stromal tumors
Carcinosarcomas
Mixed Mullerian tumors or carcinosarcomas
Metastatic carcinomas from other sites to theovary
Low malignant potential tumors, including micropapillary serouscarcinomas
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
Performance status - GOG 0-2
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
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
Creatinine no greater than 1.5 times ULN
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
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
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
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
See Disease Characteristics
No more than 12 weeks since prior surgical resection

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

4312

Study ID:

NCT00011986

Recruitment Status:

Completed

Sponsor:

Gynecologic Oncology Group

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There is 1 Location for this study

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Gynecologic Oncology Group
Philadelphia Pennsylvania, 19103, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

4312

Study ID:

NCT00011986

Recruitment Status:

Completed

Sponsor:


Gynecologic Oncology Group

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