Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment (topotecan hydrochloride, radiation, cisplatin)

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.

Group Type EXPERIMENTAL

Topotecan Hydrochloride Liposomes

Intervention Type DRUG

Given IV

3-Dimensional Conformal Radiation Therapy

Intervention Type RADIATION

Cisplatin

Intervention Type DRUG

Given IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Topotecan Hydrochloride Liposomes

Given IV

Intervention Type DRUG

3-Dimensional Conformal Radiation Therapy

Intervention Type RADIATION

Cisplatin

Given IV

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Brakiva 3D-CRT Conformal Therapy Radiation Conformal Therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter Rose

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

University of Missouri - Ellis Fischel

Columbia, Missouri, United States

Site Status

Cooper Hospital University Medical Center

Camden, New Jersey, United States

Site Status

MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Cancer Care Associates-Midtown

Tulsa, Oklahoma, United States

Site Status

Tulsa Cancer Institute

Tulsa, Oklahoma, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia Canada Japan Norway United Kingdom United States