Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix
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Purpose
RATIONALE: Drugs used in chemotherapy such as cisplatin, paclitaxel, vinorelbine, gemcitabine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen containing cisplatin is most effective in treating cervical cancer.
PURPOSE: This randomized phase III trial is studying four combination chemotherapy regimens using cisplatin to compare how well they work in treating women with stage IVB, recurrent, or persistent cancer of the cervix.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride Drug: paclitaxel Drug: topotecan hydrochloride Drug: vinorelbine tartrate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Randomized Phase III Trial Of Paclitaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin In Stage IVB, Recurrent Or Persistent Carcinoma of the Cervix |
- Quality of life as measured by the FACT-Cervical Trial Outcome of Index and the FACT-Gynecologic Oncology Group/Neurotoxicity subscale at baseline, courses 2 and 5, and 9 months after completion of study treatment [ Designated as safety issue: Yes ]
- Brief Pain Inventory [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | July 2003 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Compare the survival and response of patients with stage IVB, recurrent, or persistent carcinoma of the cervix when treated with paclitaxel and cisplatin vs vinorelbine and cisplatin vs gemcitabine and cisplatin vs topotecan and cisplatin.
- Compare the toxic effects of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.
- Arm II: Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.
- Arm III: Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.
- Arm IV: Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.
In all arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before courses 2 and 5, and at 9 months after study entry.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 600 patients (150 per treatment arm) will be accrued for this study within 4 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
- Stage IVB, recurrent, or persistent disease
- Not amenable to curative surgery and/or radiotherapy
At least 1 unidimensionally measurable lesion
- At least 20 mm by palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan
- Biopsy confirmation required if lesion is less than 30 mm
- Target lesion must be outside of a previously irradiated field
- No craniospinal metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- GOG 0-1
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 normal
- Alkaline phosphatase no greater than 3 times normal
- AST no greater than 3 times normal
Renal
- Creatinine ≤ 1.2 mg/dL OR
- Creatinine > 1.2 mg/dL but < 1.5 mg/dL AND creatinine clearance ≥ 50 mL/min
- No bilateral hydronephrosis not alleviated by ureteral stents or percutaneous drainage
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer
- No prior malignancy whose treatment contraindicates the current study therapy
- No concurrent clinically significant infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent cytokines
Chemotherapy
- At least 6 weeks since prior chemoradiotherapy and recovered
- No prior chemotherapy (except when concurrently administered with radiotherapy)
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- See Chemotherapy
- At least 3 weeks since prior radiotherapy and recovered
Surgery
- Recovered from prior surgery
Contacts and Locations
Show 172 Study Locations| Study Chair: | Bradley J. Monk, MD | Chao Family Comprehensive Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00064077 History of Changes |
| Other Study ID Numbers: | CDR0000306463, GOG-0204 |
| Study First Received: | July 8, 2003 |
| Last Updated: | July 18, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical squamous cell carcinoma 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 Vinorelbine Cisplatin Vinblastine Paclitaxel Topotecan |
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 Antineoplastic Agents, Phytogenic Tubulin Modulators |
ClinicalTrials.gov processed this record on June 13, 2013