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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006453
Recruitment Status : Completed
First Posted : July 28, 2003
Last Update Posted : December 23, 2015
European Organisation for Research and Treatment of Cancer - EORTC
NCIC Clinical Trials Group
Information provided by (Responsible Party):
AGO Study Group

Brief 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: carboplatin Drug: gemcitabine hydrochloride Phase 3

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
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
Study Start Date : September 1999
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks


  • Neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3


  • Not specified


  • Glomerular filtration rate greater than 50 mL/min


  • 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


Biologic therapy:

  • Not specified


  • 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


  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy (limited to the small pelvis)
  • Concurrent palliative radiotherapy to nontarget lesions allowed


  • See Disease Characteristics


  • At least 3 weeks since other prior investigational agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006453

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Sponsors and Collaborators
AGO Study Group
European Organisation for Research and Treatment of Cancer - EORTC
NCIC Clinical Trials Group
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Study Chair: Jacobus Pfisterer, MD University Hospital Schleswig-Holstein
Study Chair: Angel J. Lacave, MD, PhD Hospital Universitario Central de Asturias
Study Chair: Marie Plante, MD Centre Hospitalier Universitaire de Quebec
Publications of Results:
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.
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.
Kurzeder C, Zhao L, Eisenhauer EA, et al.: The impact of dose intensity on the efficacy of gemcitabine plus carboplatin (GC) therapy for recurrent platinum-sensitive ovarian cancer (PSOC): A retrospective analysis of AGO-OVAR 2.5. [Abstract] J Clin Oncol 29 (Suppl 15): A-5088, 2011.

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Responsible Party: AGO Study Group Identifier: NCT00006453    
Other Study ID Numbers: CDR0000067993
First Posted: July 28, 2003    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015
Keywords provided by AGO Study Group:
recurrent ovarian epithelial cancer
Additional relevant MeSH terms:
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Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs