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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
European Organisation for Research and Treatment of Cancer - EORTC
NCIC Clinical Trials Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006453
First received: November 6, 2000
Last updated: June 21, 2011
Last verified: June 2011
  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 3

Study Type: Interventional
Study Design: 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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006453

  Show 74 Study Locations
Sponsors and Collaborators
AGO Study Group
European Organisation for Research and Treatment of Cancer - EORTC
NCIC Clinical Trials Group
Investigators
Study Chair: Jacobus Pfisterer, MD University of Schleswig-Holstein
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.
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.

ClinicalTrials.gov Identifier: NCT00006453     History of Changes
Other 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: June 21, 2011
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on October 28, 2014