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Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy
This study is ongoing, but not recruiting participants.
First Received: November 6, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: AGO Ovarian Cancer Study Group
European Organization for Research and Treatment of Cancer
National Cancer Institute of Canada
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006453
  Purpose

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 Intervention Phase
Ovarian Cancer
Drug: carboplatin
Drug: gemcitabine hydrochloride
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 1999
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006453

  Show 74 Study Locations
Sponsors and Collaborators
AGO Ovarian Cancer Study Group
European Organization for Research and Treatment of Cancer
National Cancer Institute of Canada
Investigators
Study Chair: Jacobus Pfisterer, MD University Hospital Schleswig-Holstein - Kiel Campus
Study Chair: Angel J. Lacave, MD, PhD Hospital Universitario Central de Asturias
Study Chair: Marie Plante, MD Centre Hospitalier Universitaire de Quebec
  More Information

Additional Information:
Publications:
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, Eisenhauer E; AGO-OVAR,; NCIC CTG; EORTC GCG. Combination therapy with gemcitabine and carboplatin in recurrent ovarian cancer. Int J Gynecol Cancer. 2005 May-Jun;15 Suppl 1:36-41.
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, du Bois A, Hirte H, Lacave AJ, Wagner U, Stahle A, Stuart G, Kimmig R, Olbricht S, Le T, Emerich J, Kuhn W, Bentley J, Jackisch C, Luck HJ, Rochon J, Zimmermann AH, Eisenhauer E; AGO-OVAR; NCIC CTG; EORTC GCG. 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. 2006 Oct 10;24(29):4699-707. Epub 2006 Sep 11.

Study ID Numbers: CDR0000067993, AGOSG-OVAR-2.5, CAN-NCIC-OV15, EORTC-55005, EU-20064, NCI-V00-1601
Study First Received: November 6, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00006453     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer

Study placed in the following topic categories:
Antimetabolites
Ovarian Neoplasms
Immunologic Factors
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Carboplatin
Ovarian Diseases
Ovarian Epithelial Cancer
Immunosuppressive Agents
Antiviral Agents
Recurrence
Carcinoma
Genital Diseases, Female
Radiation-Sensitizing Agents
Ovarian Cancer
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Gemcitabine
Endocrine Gland Neoplasms
Ovarian Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Carboplatin
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 02, 2009