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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00020696




Registration number
NCT00020696
Ethics application status
Date submitted
11/07/2001
Date registered
4/02/2004
Date last updated
10/01/2012

Titles & IDs
Public title
Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
Scientific 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
Secondary ID [1] 0 0
GOG-0146M
Secondary ID [2] 0 0
CDR0000068705
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Primary Peritoneal Cavity Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - cisplatin
Treatment: Drugs - tirapazamine

Treatment: Drugs: cisplatin


Treatment: Drugs: tirapazamine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Australia New Zealand Gynaecological Oncology Trials Group - Camperdown
Recruitment postcode(s) [1] 0 0
1450 - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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California
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United States of America
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Colorado
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District of Columbia
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Florida
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Illinois
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Indiana
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Iowa
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Kentucky
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Vermont
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Virginia
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United States of America
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Washington
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Canada
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Alberta
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Canada
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Ontario
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United Kingdom
State/province [30] 0 0
England

Funding & Sponsors
Primary sponsor type
Other
Name
Gynecologic Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00020696
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Allan Covens, MD
Address 0 0
Toronto Sunnybrook Regional Cancer Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00020696