Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer

Cervical Adenocarcinoma Clinical Trial

Official title:

A PHASE I STUDY OF PELVIC RADIATION THERAPY WITH CONCOMITANT WEEKLY CISPLATIN AND TOPOTECAN CHEMOTHERAPY IN PATIENTS WITH CERVICAL CARCINOMA WITHOUT EXTRA-PELVIC METASTASIS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00054444
• Other study ID #: GOG-9913
• Secondary ID: NCI-2009-00617CD
• Status: Completed
• Phase: Phase 1
• First received: February 5, 2003
• Last updated: December 29, 2014
• Start date: September 2007

Study information

• Verified date: December 2014
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This phase I trial is studying the side effects and best way to give radiation therapy when given together with topotecan and cisplatin in treating patients with locally advanced cervical cancer. This trial is also studying the best dose of topotecan when given in this regimen. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as topotecan and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

Description:

PRIMARY OBJECTIVES:

I. Determine the safety and tolerability of pelvic radiotherapy, cisplatin, and topotecan in patients with locally advanced cervical cancer.

II. Determine the maximum tolerated dose (MTD) of topotecan when administered in this regimen in this patient population.

SECONDARY OBJECTIVES:

I. Determine the site of recurrence (local vs distant) in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of topotecan.

Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive cisplatin IV and topotecan IV over 30 minutes once weekly for a total of 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of topotecan 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. Once the MTD is determined, an additional cohort of 20 patients receives treatment as above at the MTD.

After completion of study treatment, patients are followed periodically for 5 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Histologically confirmed primary invasive carcinoma of the uterine cervix

• Stages IB2, II, IIIB, and IVA disease

• Any cell type

• No known metastasis to scalene nodes or organs outside the radiation field

• No known intraperitoneal metastases

• No evidence of extrapelvic disease based on negative CT or PET scan

• Must enroll within 8 weeks of diagnosis

• Performance status - GOG 0-2

• Absolute neutrophil count = 1,500/mm^3

• Platelet count = 100,000/mm^3

• Bilirubin = 1.5 times upper limit of normal (ULN)

• SGOT = 2.5 times ULN

• Alkaline phosphatase = 2.5 times ULN

• Creatinine normal

• Creatinine clearance > 50 mL/min

• Prior ureteral obstruction allowed provided stent or nephrostomy tube has been placed

• No renal abnormalities, such as pelvic kidney, horseshoe kidney, or prior renal transplantation that would require modification of radiation fields

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except nonmelanoma skin cancer

• No septicemia or severe infection

• No other medical or psychiatric condition that would preclude study compliance

• No prior chemotherapy for any prior malignancy

• No prior cytotoxic chemotherapy for this malignancy

• No prior radiotherapy for any prior malignancy

• No prior pelvic or abdominal radiotherapy for this malignancy

• 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, Squamous Cell
• Cervical Adenocarcinoma
• Cervical Squamous Cell 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:
• Topotecan Hydrochloride Liposomes
Given IV

Radiation:
• 3-Dimensional Conformal Radiation Therapy

Drug:
• Cisplatin
Given IV

Locations

Country	Name	City	State
United States	Cooper Hospital University Medical Center	Camden	New Jersey
United States	University of Chicago Comprehensive Cancer Center	Chicago	Illinois
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	University of Missouri - Ellis Fischel	Columbia	Missouri
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Cancer Care Associates-Midtown	Tulsa	Oklahoma
United States	Tulsa Cancer Institute	Tulsa	Oklahoma

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 patients with acute toxicity assessed by Common Terminology Criteria for Adverse Events version 3.0		Up to 30 days after completion of radiation therapy	Yes
Primary	Incidence of patients with chronic toxicity assessed by Common Toxicity Criteria Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (CTC RTOG/EORTC)		Up to 5 years	Yes
Secondary	Site of treatment failure	Identified as local versus distant.	Up to 5 years	No