National Cancer Institute National Cancer Institute
U.S. National Institutes of Health National Cancer Institute
Phase I Study of Whole Pelvic Radiotherapy and Concurrent Cisplatin and Gemcitabine in Patients With Cervical Carcinoma Limited to the Pelvis
Last Modified: 2/19/2008     First Published: 8/24/2003  

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase ITreatmentCompletedNot specifiedNCIGOG-9912
NCT00068549

Objectives

Primary

  1. Determine the toxicity of pelvic radiotherapy and concurrent cisplatin and gemcitabine in patients with cervical carcinoma limited to the pelvis.
  2. Determine the maximum tolerated dose (MTD) of gemcitabine in combination with cisplatin and pelvic radiotherapy in these patients.

Secondary

  1. Determine the progression-free and overall survival of patients treated with gemcitabine at the MTD in this regimen.
  2. Determine the site of recurrence, local versus distant, in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

  • Histologically confirmed primary invasive carcinoma of the uterine cervix
    • Previously untreated disease
    • Any cell type
    • Stage IB2, IIA, IIB, IIIA, IIIB, or IVA


  • Para-aortic lymph nodes negative by radiologic evaluation or by biopsy if CT scan is suspicious for adenopathy


  • No known metastases to scalene nodes or other organs outside the radiotherapy field


  • Study enrollment within 8 weeks of diagnosis


Prior/Concurrent Therapy:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior cytotoxic chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior pelvic or abdominal radiotherapy

Surgery

  • Not specified

Other

  • No prior therapy for this malignancy

Patient Characteristics:

Age

  • Not specified

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3

Hepatic

  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 3 times normal

Renal

  • Creatinine less than 2.0 mg/dL
  • No renal abnormalities (e.g., pelvic kidney, horseshoe kidney, or renal transplantation) that would require modification of radiotherapy fields
  • No ureteral obstruction allowed unless treated with stent or nephrostomy tube

Other

  • Not pregnant
  • Fertile patients must use effective contraception
  • No septicemia or severe infection
  • No circumstance that would preclude study completion or follow-up
  • No other malignancy within the past 5 years except nonmelanoma skin cancer

Expected Enrollment

24

A total of 3-24 patients will be accrued for this study within 1-24 months.

Outline

This is a multicenter, dose-escalation study of gemcitabine.

Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity. Patients also undergo external whole pelvis radiotherapy once daily on days 1-5, 8-13, 15-20, 22-27, and 29-34. After completion of external beam radiotherapy, patients undergo intracavitary radiotherapy and parametrial radiotherapy. The total elapsed time for completion of all radiotherapy is not more than 8 weeks.

Cohorts of 3-6 patients receive escalating doses of gemcitabine 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.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Published Results

Rose PG, DeGeest K, McMeekin DS, et al.: A phase I study of concomitant cisplatin and gemcitabine chemotherapy with whole-pelvis radiation therapy in locally advanced cervical cancer: a Gynecologic Oncology Group study. [Abstract] Society of Gynecologic Oncologists, 2007 Annual Meeting on Women's Cancer, March 3-7, 2007, San Diego, CA. A-205, 2007.

Rose PG, Degeest K, McMeekin S, et al.: A phase I study of gemcitabine followed by cisplatin concurrent with whole pelvic radiation therapy in locally advanced cervical cancer: a Gynecologic Oncology Group study. Gynecol Oncol 107 (2): 274-9, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Peter Rose, MD, Protocol chair
Ph: 216-778-5885

Registry Information
Official Title A Phase I Study of Whole Pelvic Radiation Therapy with Concomitant Cisplatin and Gemcitabine Chemotherapy in Patients with Cervical Carcinoma (Stages I-IV) Limited to the Pelvis
Trial Start Date 2003-12-03
Trial Completion Date 2008-01-26
Registered in ClinicalTrials.gov NCT00068549 1
Date Submitted to PDQ 2003-07-29
Information Last Verified 2006-11-29
NCI Grant/Contract Number CA27469

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.



Table of Links

1http://clinicaltrials.gov/ct/show/NCT00068549