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

Alternate Title

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	GOG-9907 NCT00005840

Objectives

1. Determine the safety and maximum tolerated doses of paclitaxel and cisplatin when administered with radiotherapy in patients with stage III or IV endometrial cancer.
2. Assess the time to disease progression and overall survival of patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed surgical stage III or IV endometrial cancer

  OR

• Any stage clear or serous papillary endometrial cancer
• Positive para-aortic lymph nodes allowed
• Tumor must be surgically reduced to 2 cm or less within 8 weeks of study
  • Must have had hysterectomy and bilateral salpingo-oophorectomy
• No recurrent disease
• No metastases to lung or liver parenchyma or inguinal or scalene lymph nodes

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• See Disease Characteristics
• No more than 8 weeks since prior surgery

Other:

• No prior anticancer therapy that would preclude study

Patient Characteristics:

Age:

• 18 and over

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count greater than 2,000/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT no greater than 3 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• No other prior or concurrent malignancy in the past 5 years except non-melanoma skin cancer

Expected Enrollment

A total of 3-48 patients will be accrued for part I and 14-20 patients will be accrued for part II of this study.

Outline

This is a dose-escalation study of paclitaxel and cisplatin.

Patients receive paclitaxel IV over 1 hour and cisplatin IV on days 1, 8, 15, 22, 29, and 36. Patients also undergo whole abdominal radiotherapy for 5 consecutive days weekly for 6 weeks.

Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin 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 treated at that dose level.

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

McMeekin DS, Walker JL, Hartenbach EM, et al.: Phase I trial of the treatment of high-risk endometrial cancer with concurrent weekly paclitaxel and cisplatin and whole abdominal radiation therapy: a Gynecologic Oncology Group study. Gynecol Oncol 112 (1): 134-41, 2009.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

D. Scott McMeekin, MD, Protocol chair		Ph: 405-271-8707

Registry Information
Official Title		Phase I Trial of the Treatment of Advanced Endometrial Cancer with Concurrent Weekly Paclitaxel and Cisplatin and Whole Abdominal Radiation Therapy
Trial Start Date		2000-07-17
Trial Completion Date		2009-07-17
Registered in ClinicalTrials.gov		NCT00005840
Date Submitted to PDQ		2000-04-07
Information Last Verified		2006-05-16
NCI Grant/Contract Number		CA27469

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