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

Cervical Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00068549
• Other study ID #: GOG-9912
• Secondary ID: NCI-2012-02553CD
• Status: Completed
• Phase: Phase 1
• First received: September 10, 2003
• Last updated: December 23, 2014
• Start date: October 2003

Study information

• Verified date: December 2014
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Carcinoma, Adenosquamous
• Carcinoma, Small Cell
• Carcinoma, Squamous Cell
• Cervical Adenocarcinoma
• Cervical Adenosquamous Carcinoma
• Cervical Small Cell Carcinoma
• Cervical Squamous Cell Carcinoma
• Small Cell Lung Carcinoma
• Stage IB Cervical Cancer
• Stage IIA Cervical Cancer
• Stage IIB Cervical Cancer
• Stage III Cervical Cancer
• Stage IVA Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Gemcitabine Hydrochloride
Given IV
• Cisplatin
Given IV

Radiation:
• Radiation Therapy
Undergo whole pelvis radiotherapy
• Internal Radiation Therapy
Undergo brachytherapy

Locations

Country	Name	City	State
United States	Gynecologic Oncology Group	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute toxicity using the 21 major categories of the CTEP CTC version 2.0		Up to 30 days after completion of radiation therapy	Yes
Primary	Incidence of chronic toxicity using the CTC RTOG/EORTC late radiation morbidity scoring scheme		Up to 5 years	Yes
Primary	Dose of each drug		Up to 5 years	No
Primary	Number of cycles received		Up to 5 years	No
Secondary	Site (local/distant) of treatment failure		Up to 5 years	No
Secondary	Progression-free survival		Up to 5 years	No
Secondary	Overall survival		Up to 5 years	No