Trials / Terminated
TerminatedNCT00003624
Amifostine in Treating Women With Ovarian, Peritoneal, Cervical, Fallopian Tube, Uterine, or Endometrial Cancer
A Limited Access Trial Using Amifostine for Protection Against Cisplatin and 3-Hour Paclitaxel-Induced Neurotoxicity
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Gynecologic Oncology Group · Network
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of amifostine in reducing the risk of side effects caused by cisplatin and paclitaxel in treating women who have ovarian, peritoneal, cervical, fallopian tube, uterine, or endometrial cancer.
Detailed description
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. 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. PROJECTED ACCRUAL: A total of 29-59 patients will be accrued for this study within 18-36 months.
Conditions
- Cervical Cancer
- Endometrial Cancer
- Fallopian Tube Cancer
- Neurotoxicity
- Ovarian Cancer
- Primary Peritoneal Cavity Cancer
- Sarcoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | amifostine trihydrate | |
| DRUG | cisplatin | |
| DRUG | paclitaxel |
Timeline
- Start date
- 1998-12-01
- Primary completion
- 2004-01-01
- First posted
- 2004-06-16
- Last updated
- 2013-04-11
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00003624. Inclusion in this directory is not an endorsement.