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


Authors: Sabbatini, P.; Aghajanian, C.; Dizon, D.; Anderson, S.; Dupont, J.; Brown, J. V.; Peters, W. A.; Jacobs, A.; Mehdi, A.; Rivkin, S.; Eisenfeld, A. J.; Spriggs, D.
Article Title: 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. © 2004 by American Society of Clinical Oncology.
Keywords: adult; controlled study; aged; aged, 80 and over; middle aged; unclassified drug; major clinical study; clinical trial; disease course; cancer recurrence; cancer growth; drug efficacy; drug safety; paclitaxel; neurotoxicity; antineoplastic agent; cancer grading; ovarian neoplasms; controlled clinical trial; ovary cancer; peritoneum cancer; phase 2 clinical trial; neoplasm recurrence, local; peritoneal neoplasms; neuropathy; drug resistance; pathology; drug resistance, neoplasm; disease progression; multicenter study; chemically induced disorder; tumor recurrence; ovary tumor; drug response; platinum; taxoids; uterine tube carcinoma; fallopian tube neoplasms; alopecia; neurologic disease; drug sensitivity; infusions, intravenous; drug conjugation; peritoneum tumor; intravenous drug administration; paclitaxel poliglumex; taxoid; uterine tube tumor; hypersensitivity; nervous system diseases; polyglutamic acid; humans; human; female; priority journal; article; polyglutamic acid paclitaxel; polyglutamic acid-paclitaxel
Journal Title: Journal of Clinical Oncology
Volume: 22
Issue: 22
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2004-11-15
Start Page: 4523
End Page: 4531
Language: English
DOI: 10.1200/jco.2004.12.043
PROVIDER: scopus
PUBMED: 15542803
DOI/URL:
Notes: J. Clin. Oncol. -- Cited By (since 1996):65 -- Export Date: 16 June 2014 -- CODEN: JCOND -- Source: Scopus
Altmetric Score
MSK Authors
  1. Don S Dizon
    21 Dizon
  2. Jakob Dupont
    64 Dupont
  3. Paul J Sabbatini
    199 Sabbatini
  4. David R Spriggs
    312 Spriggs