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Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
This study has been completed.
Study NCT00020696   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: July 23, 2008   History of Changes

July 11, 2001
July 23, 2008
June 2001
April 2006   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00020696 on ClinicalTrials.gov Archive Site
 
 
 
Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
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.

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.

Phase II
Interventional
Treatment
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • Drug: cisplatin
  • Drug: tirapazamine
 
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. Epub 2005 Oct 24.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
April 2006   (final data collection date for primary outcome measure)

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
Female
 
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   United Kingdom
 
NCT00020696
 
CDR0000068705, GOG-0146M
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Allan Covens, MD Edmond Odette Cancer Centre at Sunnybrook
National Cancer Institute (NCI)
March 2008

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