Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over		AGOSG-OVAR-2.5 CAN-NCIC-OV15, EORTC-55005, EU-20064, NCI-V00-1601, NCT00006453, OV15

Objectives

1. 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.
2. Compare response rate, duration of response, and survival time of patients treated with these regimens.
3. Compare the toxicity of these treatment regimens in these patients.
4. Compare quality of life of patients treated with these regimens.

Entry 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

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

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

Expected Enrollment

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

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.

Pfisterer J, Plante M, Vergote I, et al.: Gemcitabine/carboplatin (GC) vs. carboplatin (C) in platinum sensitive recurrent ovarian cancer (OVCA). Results of a Gynecologic Cancer Intergroup randomized phase III trial of the AGO OVAR, the NCIC CTG and the EORTC GCG. [Abstract] J Clin Oncol 22 (14 Suppl): A-5005, 450s, 2004.

Pfisterer J, Vergote I, Du Bois A, et al.: Combination therapy with gemcitabine and carboplatin in recurrent ovarian cancer. Int J Gynecol Cancer 15 (Suppl 1): 36-41, 2005 May-Jun.[PUBMED Abstract]

Vergote I, Plante M, Richter B, et al.: Improved progression free survival (PFS) and quality of life (QOL) in a randomised study comparing gemcitabine/carboplatinum (GC) vs. carboplatin (C) in platinum sensitive ovarian cancer (OVCA). [Abstract] Int J Gynecol Cancer 14 (Suppl 1): A-155, 45, 2004.

Pfisterer J, Plante M, Vergote I, et al.: Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: an intergroup trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG. J Clin Oncol 24 (29): 4699-707, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

AGO Ovarian Cancer Study Group

Jacobus Pfisterer, MD, Protocol chair(Contact information may not be current)		Ph: 49-431-597-4089 Email: jpfisterer@email.uni-kiel.de

European Organization for Research and Treatment of Cancer

Angel Lacave, MD, PhD, Protocol chair		Ph: 34-98-523-4498 Email: lacave@arrakis.es

NCIC-Clinical Trials Group

Marie Plante, MD, Protocol chair		Ph: 418-691-5392 Email: marie.plante@crhdq.ulaval.ca

Registry Information
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
Trial Start Date		1999-09-29
Registered in ClinicalTrials.gov		NCT00006453
Date Submitted to PDQ		2000-05-12
Information Last Verified		2008-01-09

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