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Phase II Study of 9-CRA for Locally Advanced, Inoperable, or Recurrent Carcinoma of the Cervix (Summary Last Modified 04/96)
Basic Trial Information
Objectives I. Evaluate the objective response rate, duration of response, and survival in women with advanced, locally advanced, inoperable, or recurrent carcinoma of the cervix to 9-cis-retinoic acid (9-CRA). II. Characterize the toxic effects of systemic 9-CRA. Entry Criteria Disease Characteristics: Histologically proven squamous cell or adenosquamous cell carcinoma of the uterine cervix incurable by or recurrent after radiotherapy or surgery, i.e.: Disease outside the pelvis, including lung, liver, lymph node, skin, or retroperitoneal metastases Positive para-aortic lymph nodes Recurrent disease outside prior radiotherapy field Bulky FIGO Stage IIIb disease to both pelvic sidewalls Bulky Stage Ib or II disease eligible for surgery or radiotherapy may receive protocol treatment as neoadjuvant therapy Disease bidimensionally measurable Prior/Concurrent Therapy: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy preferred (1 prior regimen allowed) No prior retinoic acid At least 4 weeks since chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: At least 2 weeks since surgery and on normal diet Patient Characteristics: Age: Any age Performance status: ECOG 0 or 1 Hematopoietic: WBC at least 4,000 Platelets at least 100,000 Hepatic: Bilirubin no greater than 3 x ULN SGOT no greater than 3 x ULN No hyperlipidemia Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No NYHA class III/IV status No uncontrolled CHF No angina Pulmonary: No chronic obstructive pulmonary disease Other: No active infection No AIDS, ARC, or HIV antibody No requirement for steroids No concurrent systemic or topical retinoids, including: Beta carotene compounds High-dose vitamin A, i.e., more than 15,000 IU/day No substance abuse or psychiatric condition that would preclude therapy No prior invasive malignancy except resected nonmelanomatous skin cancer No pregnant or nursing women Negative serum beta-HCG required of fertile women within 7 days prior to protocol therapy Effective contraception required of fertile women Expected Enrollment If at least 1 response is observed in the first 13 patients in either prior chemotherapy stratum, 14 additional patients will be entered in that stratum. Outline Single-Agent Chemotherapy. 9-cis-retinoic acid, 9-CRA, NSC-659772. Trial Lead Organizations Albert Einstein Cancer Center at Albert Einstein College of Medicine
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. |
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