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A Phase I Study of Intraperitoneal Interferon-α2band Intravenouscis-Platinum plus Cyclophosphamide Chemotherapy in Patients with Untreated Stage III Epithelial Ovarian Cancer: A Gynecologic Oncology Group Pilot Study
- Source :
- Gynecologic Oncology; November 1995, Vol. 59 Issue: 2 p267-272, 6p
- Publication Year :
- 1995
-
Abstract
- Previous clinical investigations using interferons (IFNs) have shown activity against epithelial ovarian cancer. The objective of this study was to determine the maximum tolerated dose of intraperitoneal (ip) IFN-α2bwhich could be administered in combination with intravenous (iv)cis-platinum plus cyclophosphamide chemotherapy. After comprehensive surgical staging and maximal cytoreduction, previously untreated patients with primary ovarian adenocarcinoma were entered at one of five IFN dose levels. IFN-α2b(5–30 × 106units) was administered ip on Day 1 (±Day 8).cis-Platinum (75 mg/m2) plus cyclophosphamide (750 mg/m2) were administered iv on Day 2 with prophylactic hydration and antiemetics. Courses were repeated every 3 weeks for 8 cycles. Adverse effects were recorded using standard Gynecologic Oncology Group toxicity scales. Fifteen patients with mean age 56 years (range 43–73) were entered and received a combined total of 100 treatment cycles. Catheter-related complications occurred in 8 patients, and in three cases lead to catheter removal and discontinuation of ip therapy. Two patients experienced grade 2–3 nephrotoxicity and 1 experienced grade 2 peripheral neuropathy. There was a single episode of chemical peritonitis. Myelosuppression was the dose-limiting toxicity with grade 3–4 leukopenia complicating 6, 5, 12, 11, and 17 cycles at dose levels 1–5, respectively. No patient completed planned treatment without interruption or dose reduction. Plannedcis-platinum dose intensity was most compromised at the fifth IFN-α2bdose level. The maximum tolerated dose of IFN-α2bwas determined to be 20 × 106units repeated on Days 1 and 8 of this 21-daycis-platinum plus cyclophosphamide chemotherapy cycle.
Details
- Language :
- English
- ISSN :
- 00908258 and 10956859
- Volume :
- 59
- Issue :
- 2
- Database :
- Supplemental Index
- Journal :
- Gynecologic Oncology
- Publication Type :
- Periodical
- Accession number :
- ejs773253
- Full Text :
- https://doi.org/10.1006/gyno.1995.0020