Official Title: “A Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy”

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.

Study Type: Interventional

Study Design: Treatment, Randomized

OBJECTIVES: - Compare time to progression in patients with advanced ovarian epithelial carcinoma who failed prior first-line platinum-based therapy when treated with carboplatin with or without gemcitabine. - Compare response rate, duration of response, and survival time of patients treated with these regimens. - Compare the toxicity of these treatment regimens in these patients. - Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to progression-free time (6-12 months vs more than 12 months), type of prior first-line therapy, and bidimensionally measurable disease (yes vs no). Patients are randomized to one of two treatment arms. - Arm I: Patients receive carboplatin IV over 30-60 minutes on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8. - Arm II: Patients receive carboplatin IV as in arm I. Treatment in both arms repeats every 3 weeks for up to 6-8 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each subsequent chemotherapy course, and at 50 days after study.

Patients are followed at 50 days, every 2 months for 1 year, and then every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.

Intervention(s) in this Clinical Trial

• Drug: carboplatin
• Drug: gemcitabine hydrochloride

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AGO Ovarian Cancer Study Group

Overall Clinical Trial Officials and Contacts

Jacobus Pfisterer, MD Study Chair University Hospital Schleswig-Holstein - Kiel Campus  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00006453

Study ID Number: CDR0000067993

ClinicalTrials.gov Identifier: NCT00006453

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database