Ovarian Cancer Clinical Trial
Official title:
PHASE I STUDY OF INTERFERON ENHANCED INTRAPERITONEAL RADIOIMMUNO-CHEMOTHERAPY FOR OVARIAN CANCER
Phase I trial to study the effectiveness of radiolabeled monoclonal antibody, paclitaxel, and interferon alfa in treating patients who have ovarian cancer. Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon may interfere with the growth of cancer cells. Combining monoclonal antibody, chemotherapy, and interferon alfa may kill more tumor cells.
OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) of intraperitoneal paclitaxel and topotecan
when administered as a radiosensitizer prior to intraperitoneal lutetium Lu 177 monoclonal
antibody CC49 (177Lu-CC49) following subcutaneous interferon alfa-2b (IFN-A) in patients
with persistent or recurrent ovarian cancer.
II. Determine the toxicity associated with intraperitoneal paclitaxel and topotecan in these
patients.
III. Examine the conjugate stability, pharmacokinetics, and biodistribution of 177Lu-CC49
given 48 hours after intraperitoneal paclitaxel.
IV. Determine the effects of IFN-A and intraperitoneal paclitaxel on 177Lu-CC49 tumor
localization and dosimetry estimates compared to a prior trial with 177Lu-CC49 alone.
V. Determine the MTD of yttrium Y 90 monoclonal antibody CC49 (90Y-CC49) when administered
with IFN-A and the dose of paclitaxel used at the MTD level of IFN-A, paclitaxel, and
177Lu-CC49.
VI. Monitor any antitumor effects of this treatment in these patients.
OUTLINE: This is a dose escalation study of paclitaxel, topotecan, lutetium LU 177
monoclonal antibody CC-49 (177Lu-CC49), and yttrium Y 90 monoclonal antibody CC49
(90Y-CC49).
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. Patients are followed at 6 weeks and then every 3 months for 1
year.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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