ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer

Phase 2 Completed 22 enrolled NCIC Clinical Trials Group

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ISIS 5132 in treating patients who have metastatic or recurrent ovarian cancer that has not responded to previous chemotherapy.

Timeline

Start: 1999-02-01
Primary completion: 2000-10-17
Completion: 2008-09-22

Outcome

Missed primary endpoint

paper No responses were seen in the 16 patients who are evaluable for response PMID 12694666 ↗

paper ISIS 5132 at 4 mg/kg/day as a single agent did not show activity in recurrent ovarian cancer. PMID 12694666 ↗

Publications

Results Oza AM, Elit L, Swenerton K, Faught W, Ghatage P, Carey M, McIntosh L, Dorr A, Holmlund JT, Eisenhauer E; NCIC Clinical Trials Group Study (NCIC IND.116). Phase II study of CGP 69846A (ISIS 5132) in recurrent epithelial ovarian cancer: an NCIC clinical trials group study (NCIC IND.116). Gynecol Oncol. 2003 Apr;89(1):129-33. doi: 10.1016/s0090-8258(02)00144-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ISIS 5132	Antisense oligonucleotide	4 mg/kg	Intravenous