Phase III Randomized Comparison of CDDP vs CDDP/DBD vs CDDP/IFF with Mesna in Patients with Stage IVB, Recurrent, or Persistent Squamous Cell Carcinoma of the Cervix
Basic Trial Information
|Phase III||Treatment||Completed||any age||NCI||GOG-110|
I. Compare, in a randomized Phase III setting, response rate, duration of response, progression-free interval, and survival in patients with advanced squamous cell carcinoma of the cervix randomly assigned to treatment with cisplatin vs. cisplatin/mitolactol vs. cisplatin/ifosfamide/mesna. II. Compare the toxicities of these regimens in patients with advanced cervical cancer.
Histologically confirmed advanced (Stage IVB), recurrent, or persistent squamous cell carcinoma of the cervix Not suitable for curative surgery and/or radiotherapy Measurable disease required, as defined by: Any lesion measurable by physical examination or chest x-ray Sharply defined lesion more than 3 cm on CT scan or biopsy- or cytology-confirmed lesions less than 3 cm on CT scan Measurement by ultrasound is not acceptable No bilateral hydronephrosis
Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy except as radiosensitizer Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Recovery from effects of prior radiotherapy required Surgery: Recovery from effects of prior surgery required
Age: Any age Performance status: GOG 0-2 (Karnofsky 50-100%) 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 Alkaline phosphatase no more than 3 x normal (unless elevations are caused by liver metastases) Albumin at least 3 g/dl Renal: Creatinine within normal limits Other: No second malignancy except nonmelanomatous skin cancer No clinically significant infections No pregnant or nursing women
Up to 121 evaluable patients may be entered on each treatment arm at an anticipated accrual rate of 12 patients/month. If, after 62 patients have been treated on each arm, the response rate on the DBD or IFF arm is not greater than on the CDDP alone arm, accrual to that combination will stop; if the response rate on the CDDP alone arm is equal to or greater than both combination arms, the study will be closed at that time.
Randomized study. Arm I: Single-Agent Chemotherapy. Cisplatin, CDDP, NSC-119875. Arm II: 2-Drug Combination Chemotherapy. CDDP; Mitolactol, Dibromodulcitol, DBD, NSC-104800. Arm III: 2-Drug Combination Chemotherapy with Urothelial Protection. CDDP; Ifosfamide, IFF, NSC-109724; with Mercaptoethane sulfonate, Mesna, NSC-113891.
Omura GA, Blessing J, Vaccarello L, et al.: A randomized trial of cisplatin (C) versus cisplatin + mitolactol (CM) versus cisplatin + ifosfamide (CIFX) in advanced squamous carcinoma of the cervix (SCC) by the Gynecologic Oncology Group (GOG). [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-736, 267, 1995.
Moore DH, Tian C, Monk BJ, et al.: Prognostic factors for response to cisplatin-based chemotherapy in advanced cervical carcinoma: a Gynecologic Oncology Group Study. Gynecol Oncol 116 (1): 44-9, 2010.[PUBMED Abstract]
Moore DH, Tian C, Monk BJ, et al.: Factors predictive of response to cisplatin-based chemotherapy in stage IVB persistent or recurrent cervical carcinoma: a multivariate analysis of three Gynecologic Oncology Group trials. [Abstract] J Clin Oncol 25 (Suppl 18): A-5534, 282s, 2007.
Trial Contact Information
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.