Radiolabeled Monoclonal Antibody, Paclitaxel, and Interferon Alfa in Treating Patients With Recurrent Ovarian Cancer
Ovarian Cancer, Primary Peritoneal Cavity Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent ovarian epithelial cancer, primary peritoneal cavity cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the ovary or papillary serous carcinoma of extraovarian origin Recurrent or persistent following standard surgery and 1 or 2 chemotherapy regimens (with or without paclitaxel), i.e.: persistent disease or progression after chemotherapy with nodules less than the equivalent of 5 x 5 x 5 cm Recurrent carcinoma (after primary or secondary chemotherapy) detected clinically either by exam or rising CA 125 and with radiographic evidence of disease no greater than the equivalent of 5 x 5 x 5 cm nodules Residual disease less than 5 x 5 x 5 cm following reassessment laparotomy Microscopic residual disease on reassessment laparotomy after chemotherapy Tumor TAG-72 positive by immunoperoxidase staining of original or current tumor blocks At least 85% free flow of fluid in peritoneal cavity demonstrated by technetium-99m scan or other imaging within 2 weeks prior to treatment No evidence of disease outside the peritoneal cavity other than retroperitoneal lymphadenopathy No massive ascites PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 WBC at least 3,500/mm3 Platelet count at least 125,000/mm3 Hemoglobin greater than 9 g/dL No nucleated RBC or significant teardrop RBC morphology Bilirubin less than 1.5 mg/dL AST/ALT less than 4 times normal Creatinine less than 2.0 mg/dL HIV negative Hepatitis B surface antigen negative No hypersensitivity to paclitaxel, polyoxethylated castor oil, or topotecan No other malignancy in past 5 years except basal cell skin carcinoma Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: At least 3 weeks since prior biologic therapy and recovered No prior monoclonal antibody therapy No concurrent immunotherapy No prior bone marrow or stem cell transplantation At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and recovered No concurrent chemotherapy At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to the abdominal cavity No concurrent radiotherapy At least 3 weeks since prior major surgery and recovered No prior intraperitoneal therapy
Sites / Locations
- University of Alabama Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Arm I
Patients receive interferon alfa subcutaneously on days 1, 3, 5, and 7; paclitaxel intraperitoneally (IP) on day 4 or topotecan IP on day 6; and 177Lu-CC49 IP on day 6. Treatment continues every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-5 patients receive escalating doses of paclitaxel and decreasing doses of 177Lu-CC49 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 5 patients experience dose limiting toxicity. Once the MTD of paclitaxel is determined, the dose of 177Lu-CC49 is escalated. Once the MTD of 177Lu-CC49 is determined, 90Y-CC49 is substituted. The MTD of 90Y-CC49 is then determined when administered with paclitaxel. Topotecan is then substituted for paclitaxel (administered with the MTD of 177Lu-CC49 and interferon alfa only) and escalated until the MTD is determined.