S9717 Tirapazamine Plus Cisplatin in Treating Patients With Metastatic, Recurrent, or Refractory Cervical Cancer
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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 |
- 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 |
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
Show 85 Study Locations| Study Chair: | Harriet O. Smith, MD | University of New Mexico Cancer Center |
More Information
Additional Information:
Publications:
| 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 Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases |
Genital Diseases, Female Tirapazamine Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013