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| ID | Type | Description | Link |
|---|---|---|---|
| IND No. 69,507 |
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This is a Phase II research study that is designed for patients who have small cell lung cancer (SCLC) that is no longer responding to treatment. Patients will receive picoplatin, a new platinum-based agent that is currently under investigation, in 21-day cycles.
Platinum drugs work by binding to DNA and preventing the rapid cell division of tumors. However, many tumors demonstrate a resistance to platinum drugs. Results from preclinical studies indicate that picoplatin (previously called AMD473 or ZD0473) may be able to overcome or partially overcome platinum resistance. More than 500 patients have received picoplatin in previous Phase I or Phase II clinical trials.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| picoplatin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy and safety (outcomes will be measured approximately 1 year after the last subject has been treated) |
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Main inclusion criteria:
[Additional eligibility criteria apply.]
Exclusion Criteria:
[Additional exclusion criteria apply.]
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| Name | Affiliation | Role |
|---|---|---|
| Hazel Breitz, MD | Poniard Pharmaceuticals | Study Director |
| Paul Weiden, MD | Poniard Pharmaceuticals | Study Director |
| David Karlin, MD | Poniard Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genesis Cancer Center | Hot Springs | Arkansas | 71913 | United States | ||
| Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12671715 | Background | Beale P, Judson I, O'Donnell A, Trigo J, Rees C, Raynaud F, Turner A, Simmons L, Etterley L. A Phase I clinical and pharmacological study of cis-diamminedichloro(2-methylpyridine) platinum II (AMD473). Br J Cancer. 2003 Apr 7;88(7):1128-34. doi: 10.1038/sj.bjc.6600854. | |
| 12645909 | Background | Douillard JY, Schiller J. ZD0473 combined with other chemotherapeutic agents for the treatment of solid malignancies. Eur J Cancer. 2002 Dec;38 Suppl 8:S25-31. doi: 10.1016/s0959-8049(02)80020-x. |
| Label | URL |
|---|---|
| Poniard Pharmaceuticals website | View source |
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| Los Angeles |
| California |
| United States |
| Comprehensive Cancer Center | Palm Springs | California | 92262 | United States |
| Eastern Connecticut Hematology/Oncology | Norwich | Connecticut | 06360 | United States |
| Oncology Hematology Group of South Florida | Miami | Florida | 33176 | United States |
| H. Lee Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Augusta Oncology Associates | Augusta | Georgia | 30901-5104 | United States |
| Central Georgia Hematology Oncology Associates | Macon | Georgia | 31201 | United States |
| Georgia Cancer Specialists | Tucker | Georgia | 30084 | United States |
| Rush Medical College | Chicago | Illinois | 60612-3828 | United States |
| Medical Center of Vincennes | Vincennes | Indiana | 47591 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Markey Cancer Center, University of Kentucky | Lexington | Kentucky | 40536 | United States |
| The Ochsner Clinic | New Orleans | Louisiana | 70121-2483 | United States |
| Louisiana State University Health Science Center | Shreveport | Louisiana | 71130-3932 | United States |
| University of Missouri / Ellis Fischel Cancer Center | Columbia | Missouri | 65203-3299 | United States |
| The Center for Cancer Care & Research | St Louis | Missouri | 63141 | United States |
| Hematology Oncology Centers of the Northern Rockies | Billings | Montana | 59101 | United States |
| V.A. Sierra Nevada Health Care | Reno | Nevada | 89502 | United States |
| Dartmouth-Hitchcock Medical Center Hematology/Oncology | Lebanon | New Hampshire | 03756 | United States |
| Mt. Sinai Medical Center | New York | New York | 10029 | United States |
| Southeastern Medical Oncology Center | Goldsboro | North Carolina | 27534-9479 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Consultants in Medical Oncology & Hematology | Drexel Hill | Pennsylvania | 19026 | United States |
| South Carolina Oncology Associates, PA | Columbia | South Carolina | 29210 | United States |
| The West Clinic | Memphis | Tennessee | 38120 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-6307 | United States |
| Southwest Regional Cancer Center | Austin | Texas | 78705 | United States |
| Tom Baker Cancer Center | Calgary | Alberta | T2N 4N2 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Ufa | Bashkortostan Republic | Russia |
| Stepanovskoye, Krasnogorskiy District | Moscow Oblast | Russia |
| Petrozavodsk | Republic of Karelia | Russia |
| Engel's | Saratov Oblast | Russia |
| Kazan' | Tatarstan Republic | Russia |
| Izhevsk | Udmurtiya Republic | Russia |
| Cherepovets | Vologda Oblast | Russia |
| Astrakhan | Russia |
| Barnaul | Russia |
| Chelyabinsk | Russia |
| Kaliningrad | Russia |
| Krasnodar | Russia |
| Moscow | Russia |
| Nizhny Novgorod | Russia |
| Omsk | Russia |
| Orenburg | Russia |
| Pyatigorsk | Russia |
| Rostov-on-Don | Russia |
| Saint Petersburg | Russia |
| Samara | Russia |
| Stavropol | Russia |
| Ulyanovsk | Russia |
| Voronezh | Russia |
| Yaroslavl | Russia |
| Yekaterinburg | Russia |
| 15205207 | Background | Gelmon KA, Stewart D, Chi KN, Chia S, Cripps C, Huan S, Janke S, Ayers D, Fry D, Shabbits JA, Walsh W, McIntosh L, Seymour LK. A phase I study of AMD473 and docetaxel given once every 3 weeks in patients with advanced refractory cancer: a National Cancer Institute of Canada-Clinical Trials Group trial, IND 131. Ann Oncol. 2004 Jul;15(7):1115-22. doi: 10.1093/annonc/mdh278. |
| 12649098 | Background | Gelmon KA, Vandenberg TA, Panasci L, Norris B, Crump M, Douglas L, Walsh W, Matthews SJ, Seymour LK. A phase II study of ZD0473 given as a short infusion every 3 weeks to patients with advanced or metastatic breast cancer: a National Cancer Institute of Canada Clinical Trials Group trial, IND 129. Ann Oncol. 2003 Apr;14(4):543-8. doi: 10.1093/annonc/mdg171. |
| 12647701 | Background | Giaccone G, O'Brien ME, Byrne MJ, Bard M, Kaukel E, Smit B. Phase II trial of ZD0473 as second-line therapy in mesothelioma. Eur J Cancer. 2002 Dec;38 Suppl 8:S19-24. doi: 10.1016/s0959-8049(02)80018-1. |
| 12645907 | Background | Gore ME, Atkinson RJ, Thomas H, Cure H, Rischin D, Beale P, Bougnoux P, Dirix L, Smit WM. Results of ZD0473 in platinum-pretreated ovarian cancer: analysis according to platinum free interval. Eur J Cancer. 2002 Dec;38 Suppl 8:S7-12. doi: 10.1016/s0959-8049(02)80014-4. |
| 12367792 | Background | Kawamura-Akiyama Y, Kusaba H, Kanzawa F, Tamura T, Saijo N, Nishio K. Non-cross resistance of ZD0473 in acquired cisplatin-resistant lung cancer cell lines. Lung Cancer. 2002 Oct;38(1):43-50. doi: 10.1016/s0169-5002(02)00175-7. |
| 12781432 | Background | Kanzawa F, Akiyama Y, Saijo N, Nishio K. In vitro effects of combinations of cis-amminedichloro (2-methylpyridine) platinum (II) (ZD0473) with other novel anticancer drugs on the growth of SBC-3, a human small cell lung cancer cell line. Lung Cancer. 2003 Jun;40(3):325-32. doi: 10.1016/s0169-5002(03)00072-2. |
| 12679731 | Background | Medina-Gundrum L, Cerna C, Gomez LR, Yochmowitz M, Weitman S. AMD473 (ZD0473) exhibits marked in vitro anticancer activity in human tumor specimens taken directly from patients. Anticancer Drugs. 2003 Apr;14(4):275-80. doi: 10.1097/00001813-200304000-00004. |
| 12645906 | Background | Murakami H, Tamura T, Yamada Y, Yamamoto N, Ueda Y, Shimoyama T, Saijo N. ZD0473 pharmacokinetics in Japanese patients: a Phase I dose-escalation study. Eur J Cancer. 2002 Dec;38 Suppl 8:S1-5. doi: 10.1016/s0959-8049(02)80012-0. |
| 15161002 | Background | Raaphorst GP, Yang DP, Li LF, Malone S. Comparison of human tumour cell responses to cisplatin and ZD0473 with and without irradiation. Anticancer Res. 2004 Mar-Apr;24(2B):613-8. |
| 12441268 | Background | Sharp SY, O'Neill CF, Rogers P, Boxall FE, Kelland LR. Retention of activity by the new generation platinum agent AMD0473 in four human tumour cell lines possessing acquired resistance to oxaliplatin. Eur J Cancer. 2002 Nov;38(17):2309-15. doi: 10.1016/s0959-8049(02)00244-7. |
| 12827291 | Background | Twelves C, Reck M, Anthoney A, Gatzemeier U, Kaye S. A phase I study of ZD0473 combined with paclitaxel for the treatment of solid malignancies. Cancer Chemother Pharmacol. 2003 Oct;52(4):277-81. doi: 10.1007/s00280-003-0633-9. Epub 2003 Jun 25. |
| 15292710 | Background | Plasencia C, Abad A, Martinez-Balibrea E, Taron M. Antiproliferative effects of ZD0473 (AMD473) in combination with 5-fluorouracil or SN38 in human colorectal cancer cell lines. Invest New Drugs. 2004 Nov;22(4):399-409. doi: 10.1023/B:DRUG.0000036682.99818.71. |
| 12645908 | Background | Treat J, Schiller J, Quoix E, Mauer A, Edelman M, Modiano M, Bonomi P, Ramlau R, Lemarie E. ZD0473 treatment in lung cancer: an overview of the clinical trial results. Eur J Cancer. 2002 Dec;38 Suppl 8:S13-8. doi: 10.1016/s0959-8049(02)80016-8. |
| 12460786 | Background | Gore ME, Atkinson RJ, Thomas H, Cure H, Rischin D, Beale P, Bougnoux P, Dirix L, Smit WM. A phase II trial of ZD0473 in platinum-pretreated ovarian cancer. Eur J Cancer. 2002 Dec;38(18):2416-20. doi: 10.1016/s0959-8049(02)00632-9. |
| CenterWatch clinical trials listings | View source |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D012008 | Recurrence |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C110525 | amminedichloro(2-methylpyridine)platinum(II) |
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