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Phase I Pilot Study of TAX/CBDCA/G-CSF with and without IL-6 for Untreated Suboptimal Stage III/IV Ovarian Epithelial or Primary Peritoneal Cancer
Basic Trial Information
Objectives I. Determine the maximum tolerated dose (MTD) of paclitaxel (Taxol) and carboplatin (TAX/CBDCA) with granulocyte colony stimulating factor in patients with untreated Stage III/IV ovarian epithelial or primary peritoneal cancer. II. Define further the pharmacokinetics of TAX in patients with untreated ovarian epithelial or primary peritoneal cancer. III. Determine the effect of TAX upon the pharmacokinetics and toxicity of CBDCA. IV. Define the mechanism of cytotoxicity of TAX by examining its effects on human ovarian or peritoneal cancer cells. V. Define an MTD based on thrombocytopenia, and evaluate interleukin-6 impact on thrombocytopenia, dose intensity, and cumulative dose delivery. Entry Criteria Disease Characteristics: Histologically confirmed, previously untreated, Stage III/IV primary peritoneal or ovarian epithelial cancer of the following types: Serous adenocarcinoma Endometrioid adenocarcinoma Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma No borderline carcinoma or "probably malignant" tumors No unclassified ovarian cancer Measurable or nonmeasurable disease allowed Cytologic confirmation required if entry is based on malignant pleural effusion Prior/Concurrent Therapy: Biologic therapy: No prior biologic therapy Chemotherapy: No prior cancer chemotherapy Endocrine therapy: No prior endocrine therapy Radiotherapy: No prior radiotherapy to abdomen or pelvis Surgery: Optimum surgery required (including total abdominal hysterectomy with bilateral salpingo-oophorectomy, if appropriate Patient Characteristics: Age: 18 and over Performance status: GOG 0-2 Hematopoietic: WBC at least 4,000 Platelets at least 100,000 Hepatic: Bilirubin no more than 1.5 x normal SGOT no more than 3 x normal No acute hepatitis Renal: Creatinine no more than 1.5 mg/dl Cardiovascular: No history of CHF No unstable angina No MI within 6 months No abnormal cardiac conduction (e.g., bundle branch block, A-V block) unless stable for 6 months No concurrent use of medications that may affect cardiac conduction, including: Digoxin Propranolol Calcium channel blockers Other: No septicemia or severe infection No severe GI bleeding Negative pregnancy test required of fertile patients Effective contraception required of fertile patients In patients receiving interleukin-6: No lymphoproliferative disorder No abnormal paraprotein on serum protein electrophoresis No HIV infection No autoimmune disease No chronic glomerulonephritis Expected Enrollment At least 3 patients will be entered for each dose studied. First, an MTD was determined for CBDCA with a 24-hour infusion of TAX (MTD = a target AUC of 7.5). Second, an MTD was defined for TAX with CBDCA at the MTD and with G-CSF (MTD = 175 mg/sqm). Third, a new MTD was defined for a 3-hour infusion of TAX with CBDCA with and without G-CSF (MTD = 175 mg/sqm). Fourth, a new MTD based on thrombocytopenia was defined for CBDCA with TAX/G-CSF (MTD = CBDCA at a target AUC of 10). As of July 1995, the ability of IL-6 to protect against thrombocytopenia is being evaluated with CBDCA at a target AUC of 12. As of November 1995, 3 additional patients will be treated at the CBDCA dose of a target AUC of 10 (for a total of 6 patients); the study will then close. Outline 2-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation. Paclitaxel, Taxol, TAX, NSC-125973; Carboplatin, CBDCA, NSC-241240; with Granulocyte Colony Stimulating Factor (Amgen), G-CSF, NSC-614629; with and without Interleukin-6 (Sandoz), IL-6, NSC-643497.Published Results Bookman MA, McGuire WP, Kilpatrick D, et al.: Phase-I Gynecologic Oncology Group (GOG) study of 3-hr and 24-hr paclitaxel with carboplatin as initial therapy for advanced epithelial ovarian cancer (OvCa). [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-755, 271, 1995. Related PublicationsBookman MA, McGuire WP 3rd, Kilpatrick D, et al.: Carboplatin and paclitaxel in ovarian carcinoma: a phase I study of the Gynecologic Oncology Group. J Clin Oncol 14 (6): 1895-902, 1996.[PUBMED Abstract] Trial Lead Organizations Gynecologic Oncology Group
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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