- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00068549
Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the toxicity of pelvic radiotherapy and concurrent cisplatin and gemcitabine in patients with cervical carcinoma limited to the pelvis.
II. Determine the maximum tolerated dose (MTD) of gemcitabine in combination with cisplatin and pelvic radiotherapy in these patients.
SECONDARY OBJECTIVES:
I. Determine the progression-free and overall survival of patients treated with gemcitabine at the MTD in this regimen.
II. 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19103
- Gynecologic Oncology Group
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
- Performance status - GOG 0-2
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 times normal
- SGOT no greater than 3 times normal
- 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
- 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
- No prior cytotoxic chemotherapy
- No prior pelvic or abdominal radiotherapy
- No prior therapy for this malignancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
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.
|
Given IV
Given IV
Other Names:
Undergo brachytherapy
Other Names:
Undergo whole pelvis radiotherapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of acute toxicity using the 21 major categories of the CTEP CTC version 2.0
Time Frame: Up to 30 days after completion of radiation therapy
|
Up to 30 days after completion of radiation therapy
|
Incidence of chronic toxicity using the CTC RTOG/EORTC late radiation morbidity scoring scheme
Time Frame: Up to 5 years
|
Up to 5 years
|
Dose of each drug
Time Frame: Up to 5 years
|
Up to 5 years
|
Number of cycles received
Time Frame: Up to 5 years
|
Up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival
Time Frame: Up to 5 years
|
Up to 5 years
|
Overall survival
Time Frame: Up to 5 years
|
Up to 5 years
|
Site (local/distant) of treatment failure
Time Frame: Up to 5 years
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter Rose, Gynecologic Oncology Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Neoplasms, Complex and Mixed
- Uterine Cervical Neoplasms
- Carcinoma
- Small Cell Lung Carcinoma
- Carcinoma, Adenosquamous
- Carcinoma, Small Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
Other Study ID Numbers
- GOG-9912 (Other Identifier: CTEP)
- U10CA027469 (U.S. NIH Grant/Contract)
- NCI-2012-02553 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CDR0000327715
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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