5015 Background: While most patients with advanced ovarian cancer respond to standard chemotherapy following surgery, relapses are common. In previous studies in patients with malignant ascites the trifunctional antibody catumaxomab demonstrated the ability to destroy EpCAM-positive tumor cells in the peritoneal cavity. This study was conducted primarily to evaluate the safety and tolerability of intraperitoneal (IP) catumaxomab in the consolidation setting for patients with minimal residual disease. Methods: 47 patients with advanced ovarian cancer (FIGO stage IIb-IV) with a complete response to standard chemotherapy were included in this single-arm study. For each patient a four-dose series of IP catumaxomab infusions was attempted, consisting of 10, 20, 50, and 150 μ g, respectively, by constant-rate 3-hour infusion. The primary objective was to assess the safety and tolerability of administering the planned catumaxomab therapy within a 21-day period. Patients were followed for safety for 90 days after treatment and then for 24 months post-study. Results: 32 patients (68.1%) received all 4 infusions, and 29 (61.7%) completed the four-dose series of catumaxomab infusions within 21 days. Among the 37 patients (78.7%) who received more than one infusion, 32 (86.5%) received all of the planned infusions. At sites where more than 2 patients were treated, 30 of 40 patients (75%) received all infusions within 21 days. All patients experienced at least 1 treatment-emergent adverse event (AE) assessed as related to study drug (731 total events). Most common AEs were nausea, pyrexia, vomiting and abdominal pain. AEs decreased with subsequent infusions; only 1 patient had a grade ≥ 3 AE after the fourth infusion. Kaplan-Meier estimates of PFS and OS at 24 months post treatment were 26.3% and 80.3%, respectively. Conclusions: IP catumaxomab appears tolerable as a consolidation regimen, with results reflecting data from other studies of this drug in early and late-stage ovarian cancer. While AEs were more frequent in this study, they were similar in nature to those in previous studies of this drug. Tolerability of the four-dose regimen was higher at sites where more patients were treated. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Fresenius Biotech, Fresenius Biotech GmbH AstraZeneca, Lilly Fresenius Biotech

Background. Women with ovarian cancer who experience disease progression during or within 6 months of first-line treatment with platinum-based anticancer drugs are considered to have platinum-resistant tumors. These patients have ail unfavorable prognosis, and they frequently seek complementary and alternative therapies (CAM). Historically, this represents ail understudied and underreported component of ovarian cancer treatment.Case. This report describes the case of a woman with rapidly progressive, platinum-resistant ovarian cancer. Upon initiating self-directed treatment with Haelan951 (R), a commercially available fermented soy beverage, she entered into a phase of prolonged disease stabilization including improvement in the serum tumor marker CA-125.Conclusion. Fermented soy products are known to contain high concentrations of the isoflavone, genistein, and other compounds that exhibit anticancer activity in preclinical models. This case report supports the prospective evaluation of alternative therapies such as these in patients with platinum-refractory ovarian cancer. (c) 2005 Elsevier Inc. All rights reserved.

5159 Background: Symptoms of bowel obstruction and intermittent chronic obstruction are common complications in patients (pts) with recurrent ovarian cancer. Mechanisms of bowel obstructions include intraabdominal carcinomatosis, drug-induced intestinal immobility, and intraluminal obstruction. Octreotide inhibits gastrointestinal hormonal secretion and decreases splanchnic blood flow. Sandostatin LARDepot (LAR) is a long-acting depot form of octreotide given intramuscularly (IM) once per month. Methods: The objectives of this trial were to assess efficacy and toxicities of LAR in ovarian cancer pts with chronic or intermittent bowel obstruction. Pts must have recurrent ovarian or primary peritoneal cancer, symptoms related to a non-surgically amenable bowel obstruction, and a life expectancy of >2 months. Following a test dose of short-acting octreotide to rule out a hypersensitivity reaction, subcutaneous (SQ) octreotide was started at a dose of 100 mcg 3x/day for 2 weeks (in order to quickly achieve therapeutic serum levels) along with LAR 30 mg IM qmonth. IM LAR was given until symptom progression or toxicity. Results: Since the study began in 9/02, 15 pts have been enrolled, and the study is now completed. The mean age of pts is 57 years of age. One enrolled pt never received any study drug, and data is available on 14 pts. Of the 15 pts enrolled, 13 have died from cancer progression. 3 pts received a successful test dose and one LAR injection, but were taken off study per their request. Of the 9 pts who received >2 months of LAR, the duration of LAR ranged from 2 to >12 months with a median of 4 months. No grade 3 or 4 toxicities related to LAR were seen, and LAR was well tolerated. 2 pts had skin reactions, and 1 of these 2 pts was taken off study. QOL data was collected and will be presented at ASCO. Conclusions: LAR is well tolerated following successful administration of a test dose of SQ octreotide. In this ovarian cancer population with inoperable bowel obstruction, LAR has activity in the management of symptoms of bowel obstruction and can be used safely in this population without apparent cumulative toxicity. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Novartis

Objectives. To determine the toxicity, tolerability, and feasibility of delivering combination chemotherapy with subsequent radiation therapy to women with high-risk endometrial cancer and to evaluate the long-term bowel toxicity of this regimen.Methods. The trial was approved by the Dana Farber/Partners Cancer Care (DFPCC) Institutional Review Board (IRB). Patients with stage 3 or stage 4 endometrial cancer or patients with high-risk histology and any stage disease were prospectively entered. Complete surgical staging and a normal gated blood pool scan were required prior to entry. Patients were treated with three cycles of paclitaxel (160 mg/m(2)), doxorubicin (45 mg/m(2)) and carboplatin (AUC 5) (TAC) all on day 1 of a 21-day schedule as an outpatient with G-CSF support. At the conclusion of chemotherapy, patients received radiation therapy (4500 cGy to the whole pelvis) commencing within 35 days of the last cycle of chemotherapy. Paraaortic radiation and/or vaginal brachytherapy were allowed at the discretion of the treating radiation oncologist.Results. Twenty patients were entered onto the trial from November 2000 through February 2003. Eighteen patients successfully completed the trial, and two patients came off trial during chemotherapy (both later completed planned radiation therapy). Patients were initially stage 1 (n = 3), stage 3 (n = 14), and stage 4 (n = 3). Papillary serous was the dominant histology with 13 patients. Chemotherapy was given on average within 32 days of surgery (range 11-63 days) and radiation was initiated on average within 14 weeks of surgery (range 10-18 weeks). Chemotherapy was well tolerated, with 57 total cycles delivered of a planned 60 cycles. Two patients required dose modification in two cycles (two patients in cycle 3 secondary to hematologic toxicity). No grade 3 or grade 4 neurotoxicity was reported. There were six episodes of grade 3 short-term toxicity with radiation therapy reported in a single patient. Late radiotherapy toxicity included bowel obstruction requiring laparotomy in two patients and grade 3 constipation in one patient. Late radiation toxicity data are still being collected as follow-up continues.Conclusions. The TAC chemotherapy regimen is well tolerated and three cycles were delivered successfully with G-CSF support without evidence of the neurotoxicity or cardiac toxicity reported with the cisplatin containing TAP regimen. Standard radiation was deliverable following TAC therapy without excessive toxicity. Further study of this regimen with subsequent radiation therapy is warranted in patients at risk for systemic and regional recurrence of their malignancy. (C) 2004 Elsevier Inc. All rights reserved.

Counseling Association by Dr. Garry R. Walz and Dr. Jeanne C. Bleuer of Counseling Outfitters, LLC. Its purpose is to provide a means of capturing the ideas, information and experiences generated by the annual ACA Conference and selected ACA Division Conferences. Papers on a program or practice that has been validated through research or experience may also be submitted. This digital collection of peer-reviewed articles is authored by counselors, for counselors. VISTAS Online contains the full text of over 500 proprietary counseling articles published from 2004 to present.