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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00054444
First received: February 5, 2003
Last updated: August 19, 2013
Last verified: August 2013

February 5, 2003
August 19, 2013
September 2007
January 2012   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00054444 on ClinicalTrials.gov Archive Site
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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.

Interventional
Phase 1
Primary Purpose: Treatment
Cervical Cancer
  • Drug: cisplatin
  • Drug: topotecan hydrochloride
  • Radiation: radiation therapy
Not Provided
Rose PG, Sill MW, McMeekin DS, Ahmed A, Salani R, Yamada SD, Wolfson AH, Fusco N, Fracasso PM. A phase I study of concurrent weekly topotecan and cisplatin chemotherapy with whole pelvic radiation therapy in locally advanced cervical cancer: a gynecologic oncology group study. Gynecol Oncol. 2012 Apr;125(1):158-62. doi: 10.1016/j.ygyno.2011.12.431. Epub 2011 Dec 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
January 2012   (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
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00054444
GOG-9913, CDR0000270680, NCI-2009-00617
Yes
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Peter G. Rose, MD The Cleveland Clinic
Gynecologic Oncology Group
August 2013

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