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

Alternate Title

Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Active 18 and over NCI GOG-9915 NCT00066456

Objectives

1. Determine the maximum tolerated dose of docetaxel in combination with low-dose abdominal radiotherapy in patients with recurrent or persistent advanced ovarian, peritoneal, or fallopian tube cancer.
2. Determine the safety and toxicity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Diagnosis of ovarian, peritoneal, or fallopian tube carcinoma



• Radiographic, clinical, or pathologic evidence of relapse



• Recurrent or persistent disease after chemotherapy (may be enrolled at first or subsequent relapse)
  • Received prior taxane OR platinum agent

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy to the abdomen or pelvis

Surgery

• Patients with ureteral obstruction must undergo stent or nephrostomy tube replacement prior to study entry

Patient Characteristics:

Age

• 18 and over

Performance status

• GOG 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT/SGPT no greater than 2.5 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN

Renal

• Creatinine no greater than 1.5 times ULN

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No grade 2 or greater neuropathy (sensory or motor)
• No septicemia
• No severe infection
• No circumstance that would preclude study completion

Expected Enrollment

A total of 3-30 patients will be accrued for this study within 0.25-2.5 years.

Outcomes

Dose-limiting toxicity at 1 year

Outline

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

Patients receive docetaxel IV over 30 minutes once daily on days 1, 8, 15, 22, 29, and 35. Within 3 hours after beginning docetaxel, patients also receive low-dose abdominal radiotherapy twice daily (at least 4 hours apart) on days 1, 2, 8, 9, 15, 16, 22, 24, 29, 30, 35, and 36. Treatment continues in the absence of unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 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.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Paula Fracasso, MD, PhD, Protocol chair		Ph: 314-454-8817; 800-600-3606
Katherine Look, MD, Protocol co-chair		Ph: 317-274-8987; 888-600-4822 Email: klook7711@sbcglobal.net
Richard Kryscio, PhD, Protocol co-chair		Ph: 606-257-4064

U.S.A.
Iowa
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
Ohio
	Cleveland
	Case Comprehensive Cancer Center
		Clinical Trials Office - Case Comprehensive Cancer Center	Ph:  800-641-2422
	Mentor
	Lake/University Ireland Cancer Center
		Steven Waggoner, MD	Ph:  216-844-5011
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Robert Mannel, MD	Ph:  405-271-8787
	Tulsa
	Cancer Care Associates - Saint Francis Campus
		Robert Mannel, MD	Ph:  405-271-8787

Registry Information
Official Title		A Phase I Study Using Low Dose Abdominal Radiotherapy As A Docetaxel Chemosensitizer For Recurrent , Persistent Or Advanced Ovarian, Peritoneal Or Fallopian Tube Cancer
Trial Start Date		2003-10-30
Trial Completion Date		2005-04-22 (estimated)
Registered in ClinicalTrials.gov		NCT00066456
Date Submitted to PDQ		2003-06-18
Information Last Verified		2008-12-17
NCI Grant/Contract Number		CA27469

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