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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. completion date
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


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
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