Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Brief Summary

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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. 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.

Detailed Description

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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.

Conditions

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Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Small Cell Carcinoma Cervical Squamous Cell Carcinoma Stage IB Cervical Cancer Stage IIA Cervical Cancer Stage IIB Cervical Cancer Stage III Cervical Cancer Stage IVA Cervical Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Gemcitabine Hydrochloride

Intervention Type DRUG

Given IV

Cisplatin

Intervention Type DRUG

Given IV

Radiation Therapy

Intervention Type RADIATION

Undergo whole pelvis radiotherapy

Internal Radiation Therapy

Intervention Type RADIATION

Undergo brachytherapy

Interventions

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Gemcitabine Hydrochloride

Given IV

Intervention Type DRUG

Cisplatin

Given IV

Intervention Type DRUG

Radiation Therapy

Undergo whole pelvis radiotherapy

Intervention Type RADIATION

Internal Radiation Therapy

Undergo brachytherapy

Intervention Type RADIATION

Other Intervention Names

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dFdC dFdCyd Cancer Radiotherapy Irradiate Irradiated Irradiation RT Brachytherapy Internal Radiation Internal Radiation Brachytherapy Radiation Brachytherapy

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Rose

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

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Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States