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

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Completed 18 and over NCI GOG-9803 NCT00003379

Objectives

1. Determine the toxicity of radiotherapy plus paclitaxel and cisplatin used as radiosensitization in patients with stage IB2, IIA, IIB, IIIB, or IVA invasive carcinoma of the cervix.
2. Determine the maximum tolerated dose of paclitaxel when combined with cisplatin plus radiotherapy in these patients.
3. Determine the effects of this regimen at the maximum tolerated dose on progression-free survival and overall survival in these patients.
4. Determine the site of local or distant recurrence in these patients after treatment with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically proven stage IB2, IIA, IIB, IIIB, or IVA invasive carcinoma of the uterine cervix
  • Any cell type



• No metastases to para-aortic lymph nodes, scalene nodes, or to other organs outside the radiation field at time of original staging



• Study entry required within 8 weeks of diagnosis

Prior/Concurrent Therapy:

Biologic therapy:

• No prior biologic therapy

Chemotherapy:

• No prior chemotherapy for this or any prior malignancy

Endocrine therapy:

• No prior endocrine therapy

Radiotherapy:

• No prior pelvic or abdominal radiotherapy for this malignancy
• No prior radiotherapy for any other prior malignancy
• No more than 1 month interval between surgery and radiotherapy

Surgery:

• See Radiotherapy

Other:

• No other prior therapy for this malignancy
• Stent or nephrostomy tube required if ureteral obstruction present

Patient Characteristics:

Age:

• 18 and over

Performance status:

• GOG 0-2

Life expectancy:

• More than 6 months

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 radiation fields

Other:

• Not pregnant
• No septicemia or severe infection
• No other invasive malignancy within the past 3 years except nonmelanomatous skin cancer

Expected Enrollment

A total of 20-40 patients will be accrued for this study within 3-7 years.

Outline

This is a dose escalation study of paclitaxel.

Patients undergo external beam radiotherapy (RT) to the pelvic region 5 days a week during weeks 1-5. Patients receive paclitaxel IV over 1 hour immediately followed by cisplatin concurrently with pelvic field radiotherapy on days 1, 8, 15, 22, 29, and 36. Patients undergo low-dose rate (LDR) OR high-dose rate (HDR) brachytherapy. For patients undergoing LDR brachytherapy, intracavitary implants are inserted 1 or 2 times within 3 weeks after completion of external beam RT. For patients undergoing HDR brachytherapy, intracavitary implants are inserted once a week for 5 weeks beginning during week 4 of external beam RT. Patients may receive a parametrial boost.

Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued and treated at the MTD as above.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter or at time of recurrence until death.

DiSilvestro PA, Walker JL, Morrison A, et al.: Radiation therapy with concomitant paclitaxel and cisplatin chemotherapy in cervical carcinoma limited to the pelvis: a phase I/II study of the Gynecologic Oncology Group. Gynecol Oncol 103 (3): 1038-42, 2006.[PUBMED Abstract]

Walker J, Morrison A, DiSilvestro P, et al.: GOG protocol 9803: phase I evaluation of the treatment of invasive cervical cancer confined to the pelvis with combination of radiation and weekly cisplatin and paclitaxel. [Abstract] Int J Gynecol Cancer 14 (Suppl 1): A-157, 46, 2004.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Joan Walker, MD, Protocol chair		Ph: 405-271-8707
Michael Pearl, MD, Protocol co-chair		Ph: 631-444-2774
Ming-teh Chen, MD, Protocol co-chair		Ph: 650-988-8421

Registry Information
Official Title		A Phase I/II Study Of Whole Pelvic Radiation Therapy With Concomitant Paclitaxel and Cisplatin Chemotherapy in Patients With Cervical Carcinoma (Stages I-IV) Limited to the Pelvis
Trial Start Date		1999-11-15
Trial Completion Date		2007-01-14
Registered in ClinicalTrials.gov		NCT00003379
Date Submitted to PDQ		1998-06-25
Information Last Verified		2004-11-01
NCI Grant/Contract Number		CA27469

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