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

Gynecologic Oncology Group (GOG)

Status and phase

Completed

Phase 1

Conditions

Stage IVA Cervical Cancer

Stage III Cervical Cancer

Cervical Adenocarcinoma

Stage IB Cervical Cancer

Stage IIA Cervical Cancer

Stage IIB Cervical Cancer

Cervical Squamous Cell Carcinoma

Treatments

Drug: Cisplatin

Radiation: 3-Dimensional Conformal Radiation Therapy

Drug: Topotecan Hydrochloride Liposomes

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00054444

U10CA027469 (U.S. NIH Grant/Contract)

NCI-2009-00617 (Registry Identifier)

CDR0000270680

GOG-9913

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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