|Phase II||Treatment||Closed||any age||EORTC-55871|
I. Assess the clinical efficacy of combination chemotherapy with bleomycin/methotrexate/lomustine in patients with radically inoperable squamous cell carcinoma of the vulva. II. Assess the operability of patients after this chemotherapy. III. Evaluate the side effect profile of this chemotherapy regimen.
Histologically verified, primary or recurrent squamous cell carcinoma of the vulva with radically inoperable disease but no distant metastases Bidimensionally measurable disease (WHO criteria) required No prior or concurrent radiotherapy to measurable disease
Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Prior palliative surgery allowed
Age: Any age Performance status: WHO 0-2 Hematopoietic: WBC at least 4,000 Platelets at least 130,000 Hepatic: Not specified Renal: Creatinine clearance at least 50 ml/min Pulmonary: No severely reduced lung function (as assessed by clinical exam, chest x-ray, and vital capacity) Other: No severe co-existent somatic or psychological disease, especially if likely to be aggravated by chemotherapy No second malignancy except basal cell skin carcinoma
20 patients will be treated initially, with 5 additional patients treated for each response observed in the first 20 patients, up to a maximum of 20 additional patients.
Nonrandomized study. 3-Drug Combination Chemotherapy. Bleomycin, BLM, NSC-125066; Lomustine, CCNU, NSC-79037; Methotrexate, MTX, NSC-740.
Trial Lead Organizations
European Organization for Research and Treatment of Cancer
|C. Mangioni, MD, Protocol chair|
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.