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

Alternate Title

Amifostine in Treating Women With Ovarian, Peritoneal, Cervical, Fallopian Tube, Uterine, or Endometrial Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care, Treatment	Completed	Not specified	NCI	GOG-9805 NCT00003624

Objectives

I. Determine the efficacy of amifostine in reducing significant peripheral 
neuropathy in women with ovarian, peritoneal, cervical, fallopian tube, 
uterine, or endometrial cancer treated with cisplatin and paclitaxel.

II. Determine the proportion of patients on this regimen who experience 
significant peripheral neuropathy 3 months after completing chemotherapy.

III. Assess the overall toxicity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

Ovarian, primary peritoneal, cervical, or fallopian tube carcinoma, uterine
sarcoma, or endometrial adenocarcinoma for which the proposed treatment is
cisplatin plus paclitaxel 

Must be ineligible for a higher priority GOG protocol

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 No prior chemotherapy for ovarian, primary peritoneal, or fallopian tube
  carcinoma, uterine sarcoma, or endometrial adenocarcinoma

Endocrine therapy:
 Not specified

Radiotherapy:
 No prior radiotherapy except for cervical carcinoma

Surgery:
 Not specified

Patient Characteristics:

Age:
 Not specified

Performance status:
 GOG 0-3

Life expectancy:
 Not specified

Hematopoietic:
 WBC at least 3,000/mm3
 Granulocyte 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)
 AST and alkaline phosphatase no greater than 3 times ULN

Renal:
 Creatinine no greater than 2.0 mg/dL

Cardiovascular:
 No hypertension for which medication cannot be discontinued for 24 hours
  through the day of each chemotherapy treatment

Other:
 No history of neuropathy (e.g., diabetic neuropathy)
 No significant infection
 Prior malignancy allowed if disease free for at least 12 months
 No physical disabilities precluding vibration perception threshold testing of
  the upper and lower extremity (e.g., amputation, paraplegia)

Expected Enrollment

A total of 29-59 patients will be accrued for this study within 18-36 months.

Outline

Patients receive paclitaxel IV over 3 hours, amifostine IV over 10 minutes, 
and cisplatin IV over 90 minutes.  Treatment repeats every 3 weeks for 6 
courses in the absence of disease progression or unacceptable toxicity.

Neurotoxicity is assessed and vibration perception threshold testing is 
performed prior to each course of chemotherapy and at 3 months following the 
last treatment.

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

Moore DH, Donnelly J, McGuire WP, et al.: Limited access trial using amifostine for protection against cisplatin- and three-hour paclitaxel-induced neurotoxicity: a phase II study of the Gynecologic Oncology Group. J Clin Oncol 21 (22): 4207-13, 2003.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

David Moore, MD, Protocol chair(Contact information may not be current)		Ph: 317-278-4822; 888-600-4822

Registry Information
Official Title		A Limited Access Trial Using Amifostine for Protection Against Cisplatin and 3-Hour Paclitaxel-Induced Neurotoxicity
Trial Start Date		1998-12-14
Registered in ClinicalTrials.gov		NCT00003624
Date Submitted to PDQ		1998-10-08
Information Last Verified		2006-05-18

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