S0227 Cisplatin With Either Paclitaxel or Gemcitabine in Recurrent, Persistent, or Metastatic 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. It is not yet known whether cisplatin is more effective when combined with paclitaxel or gemcitabine in treating cervical cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with paclitaxel to that of cisplatin combined with gemcitabine in treating women who have recurrent, persistent, or metastatic cervical cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride Drug: paclitaxel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Phase III Randomized Trial of Cisplatin/Paclitaxel Versus Cisplatin/Gemcitabine in Recurrent, Persistent or Metastatic Carcinoma of the Cervix |
| Enrollment: | 0 |
| Study Start Date: | April 2003 |
| Study Completion Date: | July 2003 |
| Primary Completion Date: | July 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Compare the overall survival, progression-free survival, and objective response rate (confirmed and unconfirmed, complete and partial) of patients with recurrent, persistent, or metastatic cervical cancer treated with cisplatin and paclitaxel vs cisplatin and gemcitabine.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease status at study entry (metastatic vs recurrent vs persistent), prior cisplatin as a radiosensitizer (yes vs no), and extent of disease (confined to pelvis vs extrapelvic disease). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 2 hours on day 2.
- Arm II:Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 2 hours on day 1.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this study within 4 years.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of primary carcinoma of the cervix, meeting 1 of the following staging criteria:
- Metastatic (stage IVB)
- Recurrent after prior complete response to primary treatment with surgery or radiotherapy
- Persistent after surgery or radiotherapy
- Measurable disease
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Creatinine less than upper limit of normal OR
- Creatinine clearance greater than 40 mL/min
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No grade 2 or greater sensory or motor neuropathy
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- More than 6 months since prior single-agent chemotherapy as a radiosensitizer
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 28 days since prior radiotherapy
- No prior radiotherapy to measurable target lesions
- No concurrent palliative radiotherapy
Surgery
- See Disease Characteristics
- Recovered from prior surgery
Other
- No prior systemic therapy
- No other concurrent antitumor therapy
Contacts and Locations
Show 106 Study Locations| Study Chair: | Harry J. Long, MD | Mayo Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00057928 History of Changes |
| Other Study ID Numbers: | CDR0000285630, S0227, U10CA032102 |
| Study First Received: | April 7, 2003 |
| Last Updated: | June 11, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Southwest Oncology Group:
|
recurrent cervical cancer stage IVB cervical cancer |
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 Gemcitabine Cisplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 18, 2013