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

Tracking Information

First Received Date ^ICMJE

November 6, 2000

Last Updated Date

July 23, 2008

Start Date ^ICMJE

September 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00006453 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized

Condition ^ICMJE

Ovarian Cancer

Intervention ^ICMJE

Drug: carboplatin
Drug: gemcitabine hydrochloride

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00006453

Responsible Party

Study ID Numbers ^ICMJE

CDR0000067993, AGOSG-OVAR-2.5, CAN-NCIC-OV15, EORTC-55005, EU-20064, NCI-V00-1601

Study Sponsor ^ICMJE

AGO Ovarian Cancer Study Group

Collaborators ^ICMJE

European Organization for Research and Treatment of Cancer
NCIC Clinical Trials Group

Investigators ^ICMJE

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

Information Provided By

National Cancer Institute (NCI)

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP