Phase II study of CT-2103 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.

Abstract

PURPOSE:

To evaluate the safety and efficacy of CT-2103, a novel conjugate of paclitaxel and poly-L-glutamic acid, in heavily pretreated patients with recurrent ovarian, fallopian tube, or peritoneal cancer.

PATIENTS AND METHODS:

Ninety-nine patients with measurable disease received intravenous CT-2103 at 175 mg/m2 of conjugated paclitaxel over 10 minutes every 3 weeks without routine premedications. Platinum-sensitive (n = 42) and platinum-refractory or platinum-resistant patients (n = 57) were enrolled. Thirty-nine patients (39%) had received one or two prior regimens, and 60 patients (61%) had received between three and 12 regimens.

RESULTS:

In 99 patients, the median number of cycles was three (range, one to 14 cycles). The response rate (RR) for all patients was 10% (10 of 99 patients), with median time to disease progression (TTP) of 2 months. The RR (partial response) in platinum-sensitive and platinum-resistant patients was 14% (six of 42 patients) and 7% (four of 57 patients), respectively. In patients with only one or two prior regimens, the RR in platinum-sensitive and platinum-resistant patients was 28% (five of 18 patients) and 10% (two of 21 patients), with a median TTP of 4 and 2 months, respectively. Grade 2 (15 patients) or 3 (15 patients) neuropathy was reported in 30 patients (30%). Grade 2 hypersensitivity occurred in eight patients (8%) who were subsequently treated with premedications; one patient had grade 3 hypersensitivity and was removed. Grade 2 alopecia was absent.

CONCLUSION:

CT-2103 is active in patients with recurrent ovarian cancer. Neurotoxicity in these heavily pretreated patients was more frequent than predicted from phase I trials. Further study to define toxicity and efficacy in patients with less prior therapy is ongoing.

• Authors: Paul Sabbatini, Carol Aghajanian, Don Dizon, Sybil Anderson, Jakob Dupont, John V Brown, William A Peters, Andrew Jacobs, Aminder Mehdi, Saul Rivkin, Amy J Eisenfeld, David Spriggs
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 22 Issue 22 Pg. 4523-31 (Nov 15 2004) ISSN: 0732-183X [Print] United States
• PMID: 15542803 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Taxoids
• Polyglutamic Acid
• Paclitaxel
• paclitaxel poliglumex

Topics

• Adult
• Aged
• Aged, 80 and over
• Disease Progression
• Drug Resistance, Neoplasm
• Fallopian Tube Neoplasms (drug therapy, pathology)
• Female
• Humans
• Infusions, Intravenous
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy)
• Nervous System Diseases (chemically induced)
• Ovarian Neoplasms (drug therapy, pathology)
• Paclitaxel (analogs & derivatives)
• Peritoneal Neoplasms (drug therapy, pathology)
• Polyglutamic Acid (adverse effects, pharmacology, therapeutic use)
• Taxoids (adverse effects, pharmacology, therapeutic use)