Phase III Randomized Study of Cisplatin (CDDP) versus Cisplatin plus Paclitaxel (Taxol) in Recurrent, Refractory, or Stage IVB Squamous Cell Carcinoma of the Cervix
Single-Drug Chemotherapy Versus Combination Chemotherapy in Patients With Recurrent or Refractory Cancer of the Cervix
Basic Trial Information
|Phase III||Treatment||Completed||Not specified||NCI||GOG-0169|
I. Determine whether paclitaxel plus cisplatin improves response rate in patients with recurrent, refractory, or stage IVB squamous cell carcinoma of the cervix compared to single agent cisplatin. II. Determine whether paclitaxel plus cisplatin improves progression free interval and survival compared to single agent cisplatin in these patients. III. Compare the toxic effects of these two regimens in these patients. IV. Measure health related quality of life prior to and during systemic cytotoxic therapy in these patients. V. Compare health related quality of life in these patients receiving paclitaxel plus cisplatin versus single agent cisplatin.
Histologically proven recurrent, refractory, and stage IVB squamous cell carcinoma of the cervix not amenable to curative treatment with surgery and/or radiation therapy Must have measurable lesions by physical examination, radiography, computed tomography or magnetic resonance imaging (lesions at least 3 cm can be measured by CT or MRI scan without biopsy confirmation; smaller lesions must be pathologically or cytologically confirmed) No craniospinal metastases
Biologic therapy: Not specified Chemotherapy: No prior chemotherapy except when used for radiation sensitization At least 6 weeks since chemoradiotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since radiation therapy and recovered At least 6 weeks since chemoradiotherapy and recovered No prior radiotherapy for other malignancies Surgery: Prior surgery allowed and recovered
Age: Not specified Performance Status: GOG 0-2 Life Expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 4000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3.0 times ULN Alkaline phosphatase no greater than 3.0 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: No clinically significant infection Not pregnant or nursing No concurrent malignancies other than nonmelanomatous skin cancer No bilateral hydronephrosis that cannot be alleviated by ureteral stents or percutaneous drainage No prior malignancies within at least 5 years
An anticipated 238 patients will be accrued in this study.
This is a randomized study. The study consists of two treatment arms: Arm I: Cisplatin is administered IV every 3 weeks for 6 courses Arm II: Paclitaxel is administered IV over 24 hours plus IV cisplatin every 3 weeks for 6 courses Patients will be discontinued from treatment if disease progression or unacceptable toxic effects are observed. Patients will be followed every 3 months for the first 2 years, every 6 months for the next 3 years, and then annually until death.
McQuellon RP, Thaler HT, Cella D, et al.: Quality of life (QOL) outcomes from a randomized trial of cisplatin versus cisplatin plus paclitaxel in advanced cervical cancer: a Gynecologic Oncology Group study. Gynecol Oncol 101 (2): 296-304, 2006.[PUBMED Abstract]
Moore DH, Blessing JA, McQuellon RP, et al.: Phase III study of cisplatin with or without paclitaxel in stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix: a Gynecologic Oncology Group study. J Clin Oncol 22 (15): 3113-9, 2004.[PUBMED Abstract]
Moore DH, McQuellon RP, Blessing JA, et al.: A randomized phase III study of cisplatin versus cisplatin plus paclitaxel in stage IVB, recurrent or persistent squamous cell carcinoma of the cervix. [Abstract] Society of Gynecologic Oncologists 2004 Annual Meeting on Women's Cancer, 7-11 February 2004, San Diego, California. A-348, 2004.
Chase DM, Huang HQ, Wenzel L, et al.: Quality of life and survival in advanced cervical cancer: a Gynecologic Oncology Group study. Gynecol Oncol 125 (2): 315-9, 2012.[PUBMED Abstract]
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]
Paton F, Paulden M, Saramago P, et al.: Topotecan for the treatment of recurrent and stage IVB carcinoma of the cervix. Health Technol Assess 14 (Suppl 1): 55-62, 2010.[PUBMED Abstract]
Plaxe SC, Brooks SE, Tian C, et al.: Influence of race on tolerance of platinum-based chemotherapy and clinical outcomes in women with advanced and recurrent cervical cancer: a pooled analysis of 3 Gynecologic Oncology Group studies. Am J Obstet Gynecol 199 (5): 539.e1-6, 2008.[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
Ph: 317-278-4822; 888-600-4822
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.