Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if carboplatin is more effective with or without gemcitabine for ovarian epithelial cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin with or without gemcitabine in treating patients who have advanced ovarian epithelial cancer that has not responded to previous chemotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AGO Study Group
• Collaborators: European Organisation for Research and Treatment of Cancer - EORTC; NCIC Clinical Trials Group
• Treatments: Carboplatin; Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial carcinoma not amenable to curative surgery or radiotherapy

• Evidence of recurrence or progression 6 months after discontinuation of prior first-line platinum-containing regimen

• No tumor of borderline malignancy

• Evaluable disease outside previously irradiated area

• No CNS metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Neutrophil count at least 1,500/mm3

• Platelet count at least 100,000/mm3

Hepatic:

• Not specified

Renal:

• Glomerular filtration rate greater than 50 mL/min

Other:

• No concurrent active infection

• No other primary malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer

• No other concurrent serious systemic disorder

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• No more than 1 prior platinum-based chemotherapy regimen

• No prior gemcitabine

• No other concurrent cytotoxic or antineoplastic treatment

Endocrine therapy:

• At least 3 weeks since prior hormonal therapy

• Concurrent hormone replacement therapy allowed

• Concurrent steroid antiemetics allowed

Radiotherapy:

• See Disease Characteristics

• At least 3 weeks since prior radiotherapy (limited to the small pelvis)

• Concurrent palliative radiotherapy to nontarget lesions allowed

Surgery:

• See Disease Characteristics

Other:

• At least 3 weeks since other prior investigational agents