Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer
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Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining cisplatin with gemcitabine may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine when given together with radiation therapy and cisplatin in treating patients with cervical cancer that has not spread beyond the pelvis.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride Radiation: brachytherapy Radiation: radiation therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Whole Pelvic Radiation Therapy With Concomitant Cisplatin and Gemcitabine Chemotherapy in Patients With Cervical Carcinoma (Stages I-IV) Limited to the Pelvis |
| Estimated Enrollment: | 24 |
| Study Start Date: | December 2003 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Determine the toxicity of pelvic radiotherapy and concurrent cisplatin and gemcitabine in patients with cervical carcinoma limited to the pelvis.
- Determine the maximum tolerated dose (MTD) of gemcitabine in combination with cisplatin and pelvic radiotherapy in these patients.
Secondary
- Determine the progression-free and overall survival of patients treated with gemcitabine at the MTD in this regimen.
- Determine the site of recurrence, local versus distant, in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of gemcitabine.
Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity. Patients also undergo external whole pelvis radiotherapy once daily on days 1-5, 8-13, 15-20, 22-27, and 29-34. After completion of external beam radiotherapy, patients undergo intracavitary radiotherapy and parametrial radiotherapy. The total elapsed time for completion of all radiotherapy is not more than 8 weeks.
Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 1 of 6 patients experiences dose-limiting toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 1-24 months.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary invasive carcinoma of the uterine cervix
- Previously untreated disease
- Any cell type
- Stage IB_2, IIA, IIB, IIIA, IIIB, or IVA
- Para-aortic lymph nodes negative by radiologic evaluation or by biopsy if CT scan is suspicious for adenopathy
- No known metastases to scalene nodes or other organs outside the radiotherapy field
- Study enrollment within 8 weeks of diagnosis
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- GOG 0-2
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
- SGOT no greater than 3 times normal
Renal
- Creatinine less than 2.0 mg/dL
- No renal abnormalities (e.g., pelvic kidney, horseshoe kidney, or renal transplantation) that would require modification of radiotherapy fields
- No ureteral obstruction allowed unless treated with stent or nephrostomy tube
Other
- Not pregnant
- Fertile patients must use effective contraception
- No septicemia or severe infection
- No circumstance that would preclude study completion or follow-up
- No other malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior cytotoxic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior pelvic or abdominal radiotherapy
Surgery
- Not specified
Other
- No prior therapy for this malignancy
Contacts and Locations| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Louisiana | |
| Ochsner Cancer Institute at Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at Cooper - Voorhees | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, Ohio | |
| MetroHealth's Cancer Care Center at MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| Lake/University Ireland Cancer Center | |
| Mentor, Ohio, United States, 44060 | |
| United States, Oklahoma | |
| Oklahoma University Medical Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Cancer Care Associates - Midtown Tulsa | |
| Tulsa, Oklahoma, United States, 74104 | |
| Study Chair: | Peter G. Rose, MD | MetroHealth Cancer Care Center at MetroHealth Medical Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00068549 History of Changes |
| Other Study ID Numbers: | CDR0000327715, GOG-9912 |
| Study First Received: | September 10, 2003 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
cervical squamous cell carcinoma cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical small cell carcinoma stage IB cervical cancer |
stage IIA cervical cancer stage IIB cervical cancer stage III cervical cancer stage IVA 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 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 |
ClinicalTrials.gov processed this record on May 23, 2013