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S9717 Tirapazamine Plus Cisplatin in Treating Patients With Metastatic, Recurrent, or Refractory Cervical Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003369
First Posted: June 24, 2004
Last Update Posted: June 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
  Purpose

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 combination chemotherapy consisting of tirapazamine plus cisplatin in treating patients who have metastatic, recurrent, or refractory cervical cancer.


Condition Intervention Phase
Cervical Cancer Drug: cisplatin Drug: tirapazamine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Intravenously Administered Tirapazamine Plus Cisplatin in Cervical Cancer

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • overall survival [ Time Frame: 6 months ]
    From date of registration to date of death due to any cause


Enrollment: 56
Study Start Date: August 1998
Study Completion Date: July 2004
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tirapazamine/cisplatin
tirapazamine and cisplatin given Day 1 of each 21-day treatment cycle
Drug: cisplatin
75 mg/m2 IV as a one-hour infusion after tirapazamine on Day 1 of each 21-day cycle
Other Name: platinol
Drug: tirapazamine
260 mg/m2 over two hours prior to cisplatin on Day 1 of each 21-day cycle

Detailed Description:

OBJECTIVES: I. Evaluate the survival of patients with metastatic or recurrent epithelial squamous or adenosquamous carcinoma of the cervix when treated with intravenous tirapazamine plus intravenous cisplatin. II. Evaluate the unconfirmed complete and partial response rates of these patients, as well as, the nature and degree of toxicity associated with this regimen in this patient population.

OUTLINE: Patients receive tirapazamine intravenously over 2 hours and then, following a 1 hour rest, receive cisplatin intravenously over 1 hour. Courses are repeated every 21 days. Treatment continues for 6-10 courses in the absence of unacceptable toxic effects or disease progression. All patients are followed every 6 months for 2 years, then annually thereafter until death.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed squamous or adenosquamous carcinoma of the cervix that is metastatic, recurrent, or refractory Any stage disease treated with prior radical surgery and/or definitive radiotherapy that has locally recurred and is no longer amenable to surgery or radiotherapy OR Metastatic disease that is not amenable to surgery or radiation therapy Measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.5 times upper limit of normal Other: No history of allergic reaction to mannitol Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No other prior malignancy except: Adequately treated basal cell or squamous cell skin cancer In situ cervical cancer Adequately treated stage I or II cancer from which the patient is currently in complete remission Any other cancer from which the patient has been disease free for 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factor therapy Chemotherapy: Prior chemotherapy (hydroxyurea, fluorouracil, metronidazole, cisplatin, or other platinum agent) allowed as a radiosensitizing agent only No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior radiotherapy allowed to less than 30% of the bone marrow only Recovered from toxic effects No concurrent radiotherapy Surgery: See Disease Characteristics Prior surgery allowed Recovered from effects of prior surgery Other: No prior systemic therapy for this disease

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003369


  Show 85 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Harriet O. Smith, MD University of New Mexico Cancer Center
  More Information

Publications:
Smith HO, Jiang C, Weiss GR, et al.: Tirapazamine plus cisplatin in advanced or recurrent squamous or adenosquamous carcinoma of the uterine cervix: a phase II study of the Southwest Oncology Group. [Abstract] Gynecol Oncol 92 (1): A-49, 416, 2004.

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00003369     History of Changes
Other Study ID Numbers: CDR0000066358
SWOG-S9717 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: November 1, 1999
First Posted: June 24, 2004
Last Update Posted: June 14, 2012
Last Verified: June 2012

Keywords provided by Southwest Oncology Group:
stage IV cervical cancer
recurrent cervical cancer
cervical squamous cell carcinoma
cervical adenosquamous cell carcinoma

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Tirapazamine
Cisplatin
Antineoplastic Agents