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

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed Not specified NCI GOG-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

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.

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
Date Submitted to PDQ		2003-07-29
Information Last Verified		2006-11-29
NCI Grant/Contract Number		CA27469

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