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Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Ovarian Cancer

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: NCT00102414
Recruitment Status : Completed
First Posted : January 31, 2005
Last Update Posted : November 14, 2006
Information provided by:
AGO Study Group

Brief Summary:
The primary objective of this study is to compare the time to progressive disease in patients treated with gemcitabine plus carboplatin versus carboplatin monotherapy. Patients will have advanced epithelial ovarian cancer and have failed first-line platinum-containing therapy 6 months after treatment discontinuation.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Gemcitabine Phase 3

Detailed Description:
Carboplatin is commonly used for the treatment of ovarian cancer in first- and second-line therapy. The efficacy of gemcitabine in ovarian carcinoma was researched in various Phase 2 studies.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Study Completion Date : November 2004

Primary Outcome Measures :
  1. Time to progressive disease

Secondary Outcome Measures :
  1. Response rate
  2. Duration of response
  3. Survival time
  4. Toxicity
  5. Quality of Life

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histologically proven ovarian cancer with evidence of recurrence or progression
  • Failed first-line platinum containing therapy after 6 months of treatment discontinuation
  • Documented lesion as evidenced by appropriate computerized tomography (CT), magnetic resonance imaging (MRI) scan, chest x-ray, or ultrasound.
  • Previous hormonal therapy or radiotherapy must be terminated at least 3 weeks before study drug administration
  • Adequate bone marrow reserve: neutrophils ≥ 1.5 x 10^9/L and platelets ≥ 100 x 10^9/L

Exclusion Criteria:

  • Receiving concomitant cytotoxic or other antineoplastic treatment. Hormone replacement therapy is allowed, as are steroid antiemetics
  • Clinical evidence of central nervous system metastases
  • Active infection
  • Cannot adequately be followed up for the duration of the study
  • A second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
  • Use of any investigational agent in the 3 weeks prior to inclusion
  • Serious concomitant systematic disorders incompatible with the study
  • Received more than one previous chemotherapy regimen or had prior gemcitabine treatment
  • Patients with tumor of borderline malignancy
  • Patients with estimated GFR ≤ 50 mL/min

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): NCT00102414

Sponsors and Collaborators
AGO Study Group
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Principal Investigator: Jacobus Pfisterer, Prof. Dr. med. AGO Study Group

Publications of Results:
Layout table for additonal information Identifier: NCT00102414    
Other Study ID Numbers: AGO-OVAR 2.5
First Posted: January 31, 2005    Key Record Dates
Last Update Posted: November 14, 2006
Last Verified: January 2005
Keywords provided by AGO Study Group:
Ovarian cancer
Recurrence or progression
Gemcitabine plus Carboplatin vs Carboplatin
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs