Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Neurotoxicity | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| amifostine trihydrate | Drug | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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 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) 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
References
Publications (1)
- RESULTMoore DH, Donnelly J, McGuire WP, Almadrones L, Cella DF, Herzog TJ, Waggoner SE; Gynecologic Oncology Group. 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. 2003 Nov 15;21(22):4207-13. doi: 10.1200/JCO.2003.02.086. PMID 14615449