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

Alternate Title

Radiation Therapy, Paclitaxel, and Cisplatin in Treating Patients With Cancer of the Cervix

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 18 and over NCI GOG-9804 NCT00003377

Objectives

1. Determine the toxicity of extended field radiotherapy with concurrent paclitaxel and cisplatin chemotherapy (as radiation sensitization) in patients with previously untreated carcinoma of the cervix metastatic to the para-aortic lymph nodes.
2. Determine the maximum tolerated dose of paclitaxel when combined with cisplatin plus extended field radiotherapy in this patient population.
3. Determine the effect of this treatment regimen on progression-free survival, overall survival, and site of recurrence (local vs distant) in these patients.

Entry Criteria

Disease Characteristics:

• Histologically proven previously untreated invasive carcinoma of the uterine cervix
  • Squamous cell carcinoma
  • Adenosquamous carcinoma
  • Adenocarcinoma



• TNM classification stage IIIB or IVA (FIGO classification stage IB, IIA, IIB, IIIA, IIIB, or IVA)



• Cytologically or histologically proven metastases to the para-aortic lymph nodes



• No more than 8 weeks since diagnosis



• No metastases to scalene nodes, intraperitoneal metastases, or metastases to other organs outside the radiation field at the time of original clinical and surgical staging
  • Negative CT scan of the chest



• Patients with ureteral obstruction must be treated with stent or nephrostomy tube

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior cytotoxic chemotherapy for this or other malignancy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy for this or other malignancy
• No prior radiotherapy to pelvis or abdomen

Surgery:

• Not specified

Other:

• No other prior therapy for this malignancy

Patient Characteristics:

Age:

• 18 and over

Performance status:

• GOG 0-2

Life expectancy:

• At least 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) requiring modification of radiation fields

Other:

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

Expected Enrollment

A total of 20-40 patients will be accrued for this study within 4 years.

Outcomes

Maximum tolerated dose (MTD) as assessed by CTC 3.0 after 6 weeks of treatment
Toxicity of the MTD as assessed by CTC 3.0 after 6 weeks of treatment

Disease-free survival at 2 years
Overall survival at 2 years

Outline

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

Patients receive external beam radiotherapy (RT) to the para-aortic nodes and the pelvis daily for 5 weeks; RT must be completed within 8 weeks of its initiation. During or after external beam RT, intracavitary radiation is administered 1-5 times. Concurrently with external beam RT, patients receive paclitaxel IV over 1 hour followed immediately by cisplatin IV on days 1, 8, 15, 22, 29, and 36.

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 at least 2 of 6 patients experience dose-limiting toxicity.

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

Walker JL, Morrison A, Disilvestro P, et al.: A phase I/II study of extended field radiation therapy with concomitant paclitaxel and cisplatin chemotherapy in patients with cervical carcinoma metastatic to the para-aortic lymph nodes: A gynecologic oncology group study. Gynecol Oncol : , 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Joan Walker, MD, Protocol chair		Ph: 405-271-8707

Registry Information
Official Title		A Phase I/II Study of Extended Field Radiation Therapy With Concomitant Paclitaxel and Cisplatin Chemotherapy in Patients Cervical Carcinoma Metastatic to the Para-Aortic Lymph Nodes
Trial Start Date		1999-11-15
Registered in ClinicalTrials.gov		NCT00003377
Date Submitted to PDQ		1998-06-24
Information Last Verified		2006-05-11
NCI Grant/Contract Number		CA27469

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