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Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer
This study is currently recruiting participants.
Study NCT00054444   Information provided by National Cancer Institute (NCI)
First Received: February 5, 2003   Last Updated: November 5, 2009   History of Changes

February 5, 2003
November 5, 2009
September 2007
September 2008   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00054444 on ClinicalTrials.gov Archive Site
 
 
 
Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer
A Phase I Study Of Pelvic Radiation Therapy With Concomitant Cisplatin And Weekly Topotecan (IND# 58,13) Chemotherapy In Patients With Cervical Carcinoma And Paraortic Nodal Metastasis As The Only Evidence Of Extrapelvic Disease

RATIONALE: 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.

PURPOSE: 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.

OBJECTIVES:

Primary

  • Determine the safety and tolerability of pelvic radiotherapy, cisplatin, and topotecan in patients with locally advanced cervical cancer.
  • Determine the maximum tolerated dose (MTD) of topotecan when administered in this regimen in this patient population.

Secondary

  • 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.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Phase I
Interventional
Treatment
Cervical Cancer
  • Drug: cisplatin
  • Drug: topotecan hydrochloride
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
60
 
September 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine normal OR
  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for any prior malignancy
  • No prior cytotoxic chemotherapy for this malignancy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy for any prior malignancy
  • No prior pelvic or abdominal radiotherapy for this malignancy

Surgery

  • See Patient Characteristics- Renal

Other

  • No prior therapy for this malignancy
Female
 
No
 
United States
 
NCT00054444
 
CDR0000270680, GOG-9913
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Peter G. Rose, MD The Cleveland Clinic
National Cancer Institute (NCI)
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP