Clinical trial NCT00068549: Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-09-11
Enrollment: 13
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of acute toxicity using the 21 major categories of the CTEP CTC version 2.0
timeFrame: Up to 30 days after completion of radiation therapy
measure: Incidence of chronic toxicity using the CTC RTOG/EORTC late radiation morbidity scoring scheme
timeFrame: Up to 5 years
measure: Dose of each drug
timeFrame: Up to 5 years
measure: Number of cycles received
timeFrame: Up to 5 years
Secondary outcomes:
measure: Site (local/distant) of treatment failure
timeFrame: Up to 5 years
measure: Progression-free survival
timeFrame: Up to 5 years
measure: Overall survival
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Gynecologic Oncology Group
state: Pennsylvania
Study officials:
affiliation: Gynecologic Oncology Group
name: Peter Rose
role: PRINCIPAL_INVESTIGATOR
References: