Picoplatin as Second-Line Therapy for Patients With Small Cell Lung Cancer
NCT ID: NCT00116610
Last Updated: 2009-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2005-06-30
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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picoplatin
Eligibility Criteria
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Inclusion Criteria
2. Patients must have had one prior chemotherapy regimen which must have included either cisplatin or carboplatin.
\[Additional eligibility criteria apply.\]
Exclusion Criteria
* Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom.
* Significant heart disease.
* Uncontrolled, untreated, unstable, or symptomatic brain tumors or central nervous system disease.
* Grade 2+ peripheral neuropathy (a condition caused by damage to the nerves in the peripheral nervous system).
18 Years
ALL
No
Sponsors
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Poniard Pharmaceuticals
INDUSTRY
Principal Investigators
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Hazel Breitz, MD
Role: STUDY_DIRECTOR
Poniard Pharmaceuticals
Paul Weiden, MD
Role: STUDY_DIRECTOR
Poniard Pharmaceuticals
David Karlin, MD
Role: STUDY_DIRECTOR
Poniard Pharmaceuticals
Locations
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Genesis Cancer Center
Hot Springs, Arkansas, United States
Study Site
Los Angeles, California, United States
Comprehensive Cancer Center
Palm Springs, California, United States
Eastern Connecticut Hematology/Oncology
Norwich, Connecticut, United States
Oncology Hematology Group of South Florida
Miami, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Augusta Oncology Associates
Augusta, Georgia, United States
Central Georgia Hematology Oncology Associates
Macon, Georgia, United States
Georgia Cancer Specialists
Tucker, Georgia, United States
Rush Medical College
Chicago, Illinois, United States
Medical Center of Vincennes
Vincennes, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Markey Cancer Center, University of Kentucky
Lexington, Kentucky, United States
The Ochsner Clinic
New Orleans, Louisiana, United States
Louisiana State University Health Science Center
Shreveport, Louisiana, United States
University of Missouri / Ellis Fischel Cancer Center
Columbia, Missouri, United States
The Center for Cancer Care & Research
St Louis, Missouri, United States
Hematology Oncology Centers of the Northern Rockies
Billings, Montana, United States
V.A. Sierra Nevada Health Care
Reno, Nevada, United States
Dartmouth-Hitchcock Medical Center Hematology/Oncology
Lebanon, New Hampshire, United States
Mt. Sinai Medical Center
New York, New York, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States
Providence Portland Medical Center
Portland, Oregon, United States
Consultants in Medical Oncology & Hematology
Drexel Hill, Pennsylvania, United States
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States
The West Clinic
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Southwest Regional Cancer Center
Austin, Texas, United States
Tom Baker Cancer Center
Calgary, Alberta, Canada
Princess Margaret Hospital
Toronto, Ontario, 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
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Poniard Pharmaceuticals website
CenterWatch clinical trials listings
Other Identifiers
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IND No. 69,507
Identifier Type: -
Identifier Source: secondary_id
0402
Identifier Type: -
Identifier Source: org_study_id
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