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Ovarian CancerPhase 2NCT00020696

Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer

A Phase 2 study testing cisplatin and tirapazamine in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by Gynecologic Oncology Group at 54 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Any age, women only
What is being tested?
cisplatin and tirapazamine
How many people
Not given
Where
54 sitesin 4 countries
Study dates
Jun 2001to Apr 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

54 sites in 4 countries.

54 sites in 4 countries

United States50 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Cancer Center of Albany Medical Center

    Albany, New York, 12208

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

  • Radiation Oncology Branch

    Bethesda, Maryland, 20892

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • Tufts University School of Medicine

    Boston, Massachusetts, 02111

  • State University of New York Health Science Center at Brooklyn

    Brooklyn, New York, 11203

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Fletcher Allen Health Care - Medical Center Campus

    Burlington, Vermont, 05401

  • Cooper Hospital/University Medical Center

    Camden, New Jersey, 08103

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois, 60612

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Barrett Cancer Center, The University Hospital

    Cincinnati, Ohio, 45219

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210-1240

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • University of Colorado Cancer Center

    Denver, Colorado, 80010

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Holden Comprehensive Cancer Center at The University of Iowa

    Iowa City, Iowa, 52242-1009

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0084

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • Community Hospital of Los Gatos

    Los Gatos, California, 95032

  • North Shore University Hospital

    Manhasset, New York, 11030

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Brookview Research, Inc.

    Nashville, Tennessee, 37203

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma, 73190

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104-4283

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • State University of New York Health Sciences Center - Stony Brook

    Stony Brook, New York, 11790-7775

  • Tacoma General Hospital

    Tacoma, Washington, 98405

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Canada2 sites

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Australia1 site

  • Australia New Zealand Gynaecological Oncology Trials Group

    Camperdown, New South Wales, 1450

Other trials in Australia

United Kingdom1 site

  • University of Birmingham

    Birmingham, England, B15 2TT

Other trials in United Kingdom

About this study

Official title: A Phase II Evaluation of Tirapazamine (NSC #130181, IND #46,525) in Combination With Cisplatin in Recurrent Platinum Sensitive Ovarian or Primary Peritoneal Cancer

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.

Read the detailed 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.

Being tested
cisplatin, tirapazamine
Keywords
recurrent ovarian epithelial cancer, primary peritoneal cavity cancer
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2004 (estimated)
  2. Study startJun 2001
  3. Primary completionApr 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00020696
Sponsor's protocol ID
CDR0000068705
Other IDs
GOG-0146M
Status last verified
Mar 2008
First submitted
11 Jul 2001
Last updated
10 Jan 2012
Results posted
No

Publications

  • 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. Gynecol Oncol. 2006 Mar;100(3):586-90. doi: 10.1016/j.ygyno.2005.09.032. Epub 2005 Oct 24.

    PubMed 16249022

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin and tirapazamine in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by Gynecologic Oncology Group at 54 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Canada, Australia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00020696, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2012.

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