Picoplatin as Second-Line Therapy for Patients With Small Cell Lung Cancer
A Phase II Study of Picoplatin as Second-Line Therapy for Subjects With Resistant or Refractory Small Cell Lung Cancer
2 other identifiers
interventional
75
3 countries
55
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2005
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 29, 2005
CompletedFirst Posted
Study publicly available on registry
June 30, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedJanuary 21, 2009
February 1, 2007
1.7 years
June 29, 2005
January 19, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy and safety (outcomes will be measured approximately 1 year after the last subject has been treated)
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of small cell lung cancer.
- Patients must have had one prior chemotherapy regimen which must have included either cisplatin or carboplatin.
- \[Additional eligibility criteria apply.\]
You may not qualify if:
- Prior radiotherapy that included \> 30% of the bone marrow (i.e., the whole of the pelvis or half of the spine).
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (55)
Genesis Cancer Center
Hot Springs, Arkansas, 71913, United States
Study Site
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
Unknown Facility
Ufa, Bashkortostan Republic, Russia
Unknown Facility
Stepanovskoye, Krasnogorskiy District, Moscow Oblast, Russia
Unknown Facility
Petrozavodsk, Republic of Karelia, Russia
Unknown Facility
Engel's, Saratov Oblast, Russia
Unknown Facility
Kazan', Tatarstan Republic, Russia
Unknown Facility
Izhevsk, Udmurtiya Republic, Russia
Unknown Facility
Cherepovets, Vologda Oblast, Russia
Unknown Facility
Astrakhan, Russia
Unknown Facility
Barnaul, Russia
Unknown Facility
Chelyabinsk, Russia
Unknown Facility
Kaliningrad, Russia
Unknown Facility
Krasnodar, Russia
Unknown Facility
Moscow, Russia
Unknown Facility
Nizhny Novgorod, Russia
Unknown Facility
Omsk, Russia
Unknown Facility
Orenburg, Russia
Unknown Facility
Pyatigorsk, Russia
Unknown Facility
Rostov-on-Don, Russia
Unknown Facility
Saint Petersburg, Russia
Unknown Facility
Samara, Russia
Unknown Facility
Stavropol, Russia
Unknown Facility
Ulyanovsk, Russia
Unknown Facility
Voronezh, Russia
Unknown Facility
Yaroslavl, Russia
Unknown Facility
Yekaterinburg, Russia
Related Publications (16)
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.
PMID: 12671715BACKGROUNDDouillard 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.
PMID: 12645909BACKGROUNDGelmon 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.
PMID: 15205207BACKGROUNDGelmon 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.
PMID: 12649098BACKGROUNDGiaccone 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.
PMID: 12647701BACKGROUNDGore 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.
PMID: 12645907BACKGROUNDKawamura-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.
PMID: 12367792BACKGROUNDKanzawa 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.
PMID: 12781432BACKGROUNDMedina-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.
PMID: 12679731BACKGROUNDMurakami 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.
PMID: 12645906BACKGROUNDRaaphorst 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.
PMID: 15161002BACKGROUNDSharp 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.
PMID: 12441268BACKGROUNDTwelves 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.
PMID: 12827291BACKGROUNDPlasencia 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.
PMID: 15292710BACKGROUNDTreat 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.
PMID: 12645908BACKGROUNDGore 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.
PMID: 12460786BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hazel Breitz, MD
Poniard Pharmaceuticals
- STUDY DIRECTOR
Paul Weiden, MD
Poniard Pharmaceuticals
- STUDY DIRECTOR
David Karlin, MD
Poniard Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 29, 2005
First Posted
June 30, 2005
Study Start
June 1, 2005
Primary Completion
March 1, 2007
Study Completion
March 1, 2008
Last Updated
January 21, 2009
Record last verified: 2007-02