Multi-institutional phase 2 study of TLK286 (TELCYTA™, a glutathione S-transferase P1-1 activated glutathione analog prodrug) in patients with platinum and paclitaxel refractory or resistant ovarian cancer Journal Article
| Authors: | Kavanagh, J. J.; Gershenson, D. M.; Choi, H.; Lewis, L.; Patel, K.; Brown, G. L.; Garcia, A.; Spriggs, D. R. |
| Article Title: | Multi-institutional phase 2 study of TLK286 (TELCYTA™, a glutathione S-transferase P1-1 activated glutathione analog prodrug) in patients with platinum and paclitaxel refractory or resistant ovarian cancer |
| Abstract: | The purpose of this study was to determine the safety and efficacy of TLK286 (TELCYTA™), a glutathione analog prodrug, in patients with platinum and paclitaxel refractory or resistant ovarian carcinoma. Thirty-six patients with measurable disease were enrolled. TLK286 was administered at 1000 mg/m 2 intravenously every 3 weeks. The endpoints were objective response rate assessed by Response Evaluation Criteria in Solid Tumors (RECIST) and survival. Adverse events were graded using the National Cancer Institute Common Toxicity Criteria. Thirty-four platinum refractory or resistant patients (94%) were evaluable for objective tumor response. Five patients (15%) had objective tumor responses, including one durable complete response (CR) of greater than 3 years and continuing. The disease stabilization rate was 50%, including one CR (3%), four partial responses (12%), and 12 durable disease stabilizations (35%). Responses were accompanied by improvement in clinical symptoms and Eastern Cooperative Oncology Group Performance Status (ECOG PS) and decline in CA125 levels. Median survival was 423 days with survival of 60% at 1 year and 40% at 18 months. TLK286 was well tolerated in this population. TLK286 is an active agent in chemotherapy-resistant ovarian cancer. Further studies of TLK286 in platinum and paclitaxel refractory or resistant ovarian cancer are in progress. © 2005 IGCS. |
| Keywords: | adult; clinical article; controlled study; aged; middle aged; survival analysis; unclassified drug; clinical trial; drug tolerability; fatigue; neutropenia; cisplatin; doxorubicin; dose response; drug efficacy; drug safety; gemcitabine; paclitaxel; topotecan; follow up; lymph node metastasis; ovarian cancer; ovarian neoplasms; controlled clinical trial; liver toxicity; nephrotoxicity; phase 2 clinical trial; blood toxicity; nausea; vomiting; drug administration schedule; antineoplastic agents, phytogenic; drug resistance, neoplasm; hematuria; docetaxel; survival time; liver metastasis; lung metastasis; symptom; multicenter study; carcinoma; ovary carcinoma; glutathione transferase; urinary frequency; platinum derivative; ca 125 antigen; peritoneum metastasis; infusions, intravenous; glutathione; dysuria; bladder disease; prodrug; canfosfamide; glutathione analog prodrug; glutathione s-transferases p1-1; platinum refractory or resistant; telcyta; tlk286; glutathione derivative |
| Journal Title: | International Journal of Gynecological Cancer |
| Volume: | 15 |
| Issue: | 4 |
| ISSN: | 1048-891X |
| Publisher: | Lippincott Williams & Wilkins |
| Date Published: | 2005-07-01 |
| Start Page: | 593 |
| End Page: | 600 |
| Language: | English |
| DOI: | 10.1111/j.1525-1438.2005.00114.x |
| PUBMED: | 16014111 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 36" - "Export Date: 24 October 2012" - "CODEN: IJGCE" - "Source: Scopus" |
