Phase III Randomized Comparison of Intravenous CTX plus Intraperitoneal vs Intravenous CACP in Patients with Nonmeasurable (Optimal) Stage III Ovarian Carcinoma
Basic Trial Information
|Phase III||Treatment||Completed||18 and over||NCI||SWOG-8501|
EST-3885, GOG-104, INT-0051
I. Compare in a randomized Phase III setting the therapeutic efficacy of and toxicities associated with intermediate-dose intraperitoneal vs. intravenous cis-platinum when combined with intravenous cyclophosphamide in patients with optimal Stage III ovarian carcinoma. II. Determine whether the human tumor clonogenic assay with a wide range of drug concentration testing can accurately predict pathologic complete response to 2-drug combination chemotherapy in the setting of systemic and intraperitoneal drug administration.
Histologically confirmed ovarian carcinoma of epithelial origin, i.e.: Serous cystadenocarcinoma Undifferentiated adenocarcinoma Endometrioid adenocarcinoma Mucinous cystadenocarcinoma Mesonephroid adenocarcinoma Mixed epithelial carcinoma No mixed germinal or stromal cell types No borderline or "probably malignant" tumors Pathologically confirmed surgically optimal Stage III disease required, i.e.: No residual disease at the time of surgery OR Residual disease with no lesions greater than 2 cm in largest diameter in abdomen or pelvis Registration allowed with only clinical confirmation of surgically optimal Stage III disease (final validation of eligibility requires pathologic confirmation)
Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior pelvic irradiation Surgery: Bilateral salpingo-oophorectomy and total abdominal hysterectomy with omentectomy required within 4 weeks prior to entry
Age: 18 and over Performance status: SWOG 0-2 Hematopoietic: WBC at least 3,500 Platelets at least 100,000 Hepatic: Not specified Renal: Creatinine no more than 1.5 mg/dl Creatinine clearance at least 40 ml/min Other: No septicemia or severe infection No severe gastrointestinal symptoms (i.e., partial obstruction) No bleeding No prior or concurrent malignancy except: Nonmelanomatous skin cancer Cervical carcinoma in situ Blood/body fluid analyses to determine eligibility and imaging studies and physical exams for tumor measurement completed within 14 days prior to registration; screening exams other than blood/body fluid analyses and imaging studies of nonmeasurable disease or uninvolved organs completed within 42 days prior to registration
About 450 patients will be randomized during the 3.5-year accrual period.
Randomized study. Arm I: 2-Drug Combination Chemotherapy. Intravenous cis-Platinum, CACP, NSC-119875; Intravenous Cyclophosphamide, CTX, NSC-26271. Arm II: 2-Drug Combination Chemotherapy. Intraperitoneal CACP; Intravenous CTX.
Alberts DS, Liu PY, Hannigan EV, et al.: Phase III study of IP cisplatin plus IV cyclophosphamide vs IV cisplatin plus IV cyclphosphamide in optimal disease stage III ovarian cancer: an Intergroup study 0051 (SWOG-GOG-ECOG). [Abstract] Society of Gynecologic Oncologists Abstract Book 1: 40, 1996.
Alberts DS, Liu PY, Hannigan EV, et al.: Intraperitoneal cisplatin plus intravenous cyclophosphamide versus intravenous cisplatin plus intravenous cyclophosphamide for stage III ovarian cancer. N Engl J Med 335 (26): 1950-5, 1996.[PUBMED Abstract]
Alberts DS, Liu PY, Hannigan EV, et al.: Phase III study of intraperitoneal (ip) cisplatin (CDDP)/intravenous (iv) cyclophosphamide (CPA) vs iv CDDP/iv CPA in patients (pts) with optimal disease stage III ovarian cancer: a SWOG-GOG-ECOG intergroup study (INT 0051). [Abstract] Proceedings of the American Society of Clinical Oncology 14: A760, 273, 1995.
Alberts DS, Delforge A: Maximizing the delivery of intraperitoneal therapy while minimizing drug toxicity and maintaining quality of life. Semin Oncol 33 (6 Suppl 12): S8-17, 2006.[PUBMED Abstract]
Markman M: Clinical efficacy supporting the role of intraperitoneal drug delivery in the primary chemotherapeutic management of small-volume residual advanced ovarian cancer. Semin Oncol 33 (6 Suppl 12): S3-7, 2006.[PUBMED Abstract]
Singhal P, Lele S: Intraperitoneal chemotherapy for ovarian cancer: where are we now? J Natl Compr Canc Netw 4 (9): 941-6, 2006.[PUBMED Abstract]
Heddens D, Alberts DS, Hannigan EV, et al.: Prediction of the need for red cell transfusion in newly diagnosed ovarian cancer patients undergoing platinum-based treatment. Gynecol Oncol 86 (3): 239-43, 2002.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
Southwest Oncology Group
Ph: 520-626-7685; 800-622-2673
Gynecologic Oncology Group
Ph: 317-278-0070; 888-600-4822
Eastern Cooperative 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.