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


Phase 2
N/A
N/A
Not Enrolling
Female
Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II Evaluation of Tirapazamine (NSC #130181, IND #46,525) in Combination With Cisplatin in Recurrent Platinum Sensitive Ovarian 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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Allan Covens, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Odette Cancer Centre at Sunnybrook

Authority:

United States: Federal Government

Study ID:

CDR0000068705

NCT ID:

NCT00020696

Start Date:

June 2001

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Tacoma General HospitalTacoma, Washington  98405
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Community Hospital of Los GatosLos Gatos, California  95032
Holden Comprehensive Cancer Center at The University of IowaIowa City, Iowa  52242-1009
Tufts University School of MedicineBoston, Massachusetts  02111
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Brookview Research, Inc.Nashville, Tennessee  37203
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
North Shore University HospitalManhasset, New York  11030
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Fletcher Allen Health Care - Medical Center CampusBurlington, Vermont  05401
Radiation Oncology BranchBethesda, Maryland  20892
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182