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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00003369
First received: November 1, 1999
Last updated: June 13, 2012
Last verified: June 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003369

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

Additional 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, U10CA032102
Study First Received: November 1, 1999
Last Updated: June 13, 2012
Health Authority: United States: Federal Government

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
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Cisplatin
Tirapazamine
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014