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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00020696
Other study ID # CDR0000068705
Secondary ID GOG-0146M
Status Completed
Phase Phase 2
First received July 11, 2001
Last updated January 7, 2012
Start date June 2001

Study information

Verified date March 2008
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

PURPOSE: Phase II trial to study the effectiveness of combining tirapazamine with cisplatin in treating patients who have recurrent ovarian epithelial or primary peritoneal cancer.


Description:

OBJECTIVES:

- Determine the antitumor activity of tirapazamine and cisplatin in patients with persistent or recurrent platinum-sensitive ovarian epithelial or primary peritoneal carcinoma.

- Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive tirapazamine IV over 2 hours followed 1 hour later by cisplatin IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-65 patients will be accrued for this study.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date April 2006
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility DISEASE CHARACTERISTICS:

- Histologically confirmed persistent or recurrent ovarian epithelial or primary peritoneal carcinoma

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

- Platinum-sensitive disease

- Treatment-free interval of more than 6 months without clinical evidence of progressive disease after a response to a platinum compound

- One prior chemotherapy regimen containing cisplatin or another platinum compound for primary disease required

- Initial treatment may include high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment

- Patients not previously treated with paclitaxel may receive a second regimen containing paclitaxel

- No additional cytotoxic chemotherapy (including retreatment with initial regimens) for recurrent or persistent disease

- Ineligible for a higher priority GOG protocol (any active GOG phase III protocol for the same patient population)

- Treatment-free interval of more than 12 months if non-platinum-based GOG-0146 series protocol is active concurrently with this protocol

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- GOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT no greater than 2.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No prior or concurrent myocardial infarction or ischemic heart disease

Other:

- No active infection requiring antibiotics

- No sensory or motor neuropathy greater than grade 1

- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 3 weeks since prior biologic or immunological agents directed at malignant tumor

Chemotherapy:

- See Disease Characteristics

- Recovered from prior chemotherapy

- No prior tirapazamine

Endocrine therapy:

- At least 1 week since prior hormonal therapy directed at malignant tumor

- Concurrent hormone replacement therapy allowed

Radiotherapy:

- Recovered from prior radiotherapy

- No prior radiotherapy to site(s) of measurable disease used on this study

- No prior radiotherapy to more than 25% of bone marrow

Surgery:

- See Disease Characteristics

- Recovered from prior surgery

Other:

- No prior cancer treatment that would preclude study

- At least 3 weeks since other prior therapy directed at malignant tumor

Study Design

Primary Purpose: Treatment


Intervention

Drug:
cisplatin

tirapazamine


Locations

Country Name City State
Australia Australia New Zealand Gynaecological Oncology Trials Group Camperdown New South Wales
Canada Tom Baker Cancer Center - Calgary Calgary Alberta
Canada Toronto Sunnybrook Regional Cancer Centre Toronto Ontario
United Kingdom University of Birmingham Birmingham England
United States Abington Memorial Hospital Abington Pennsylvania
United States Cancer Center of Albany Medical Center Albany New York
United States Radiation Oncology Branch Bethesda Maryland
United States Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda Maryland
United States University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama
United States Tufts University School of Medicine Boston Massachusetts
United States State University of New York Health Science Center at Brooklyn Brooklyn New York
United States Roswell Park Cancer Institute Buffalo New York
United States Fletcher Allen Health Care - Medical Center Campus Burlington Vermont
United States Cooper Hospital/University Medical Center Camden New Jersey
United States Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Cancer Center at the University of Virginia Charlottesville Virginia
United States Rush-Presbyterian-St. Luke's Medical Center Chicago Illinois
United States University of Chicago Cancer Research Center Chicago Illinois
United States Barrett Cancer Center, The University Hospital Cincinnati Ohio
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States Ireland Cancer Center Cleveland Ohio
United States Ellis Fischel Cancer Center - Columbia Columbia Missouri
United States Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio
United States Simmons Cancer Center - Dallas Dallas Texas
United States University of Colorado Cancer Center Denver Colorado
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States Duke Comprehensive Cancer Center Durham North Carolina
United States Milton S. Hershey Medical Center Hershey Pennsylvania
United States University of Texas - MD Anderson Cancer Center Houston Texas
United States Indiana University Cancer Center Indianapolis Indiana
United States Holden Comprehensive Cancer Center at The University of Iowa Iowa City Iowa
United States University of Mississippi Medical Center Jackson Mississippi
United States Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky
United States Jonsson Comprehensive Cancer Center, UCLA Los Angeles California
United States Community Hospital of Los Gatos Los Gatos California
United States North Shore University Hospital Manhasset New York
United States University of Minnesota Cancer Center Minneapolis Minnesota
United States Brookview Research, Inc. Nashville Tennessee
United States Memorial Sloan-Kettering Cancer Center New York New York
United States University of Oklahoma College of Medicine Oklahoma City Oklahoma
United States Chao Family Comprehensive Cancer Center Orange California
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania
United States University of Pennsylvania Cancer Center Philadelphia Pennsylvania
United States Mayo Clinic Cancer Center Rochester Minnesota
United States Washington University School of Medicine Saint Louis Missouri
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States State University of New York Health Sciences Center - Stony Brook Stony Brook New York
United States Tacoma General Hospital Tacoma Washington
United States H. Lee Moffitt Cancer Center and Research Institute Tampa Florida
United States Walter Reed Army Medical Center Washington District of Columbia
United States Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina
United States University of Massachusetts Memorial Medical Center Worcester Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Gynecologic Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  United Kingdom, 

References & Publications (1)

Covens A, Blessing J, Bender D, Mannel R, Morgan M; Gynecologic Oncology Group. A phase II evaluation of tirapazamine plus cisplatin in the treatment of recurrent platinum-sensitive ovarian or primary peritoneal cancer: a Gynecologic Oncology Group study. — View Citation

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