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Picoplatin as Second-Line Therapy for Patients With Small Cell Lung Cancer

Primary Purpose

Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
picoplatin
Sponsored by
Poniard Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring small cell lung cancer, resistant, refractory, platinum, chemotherapy, second-line, relapse, sensitive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main inclusion criteria: 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.] Exclusion Criteria: 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). [Additional exclusion criteria apply.]

Sites / Locations

  • Genesis Cancer Center
  • Study Site
  • Comprehensive Cancer Center
  • Eastern Connecticut Hematology/Oncology
  • Oncology Hematology Group of South Florida
  • H. Lee Moffitt Cancer Center
  • Augusta Oncology Associates
  • Central Georgia Hematology Oncology Associates
  • Georgia Cancer Specialists
  • Rush Medical College
  • Medical Center of Vincennes
  • University of Kansas Medical Center
  • Markey Cancer Center, University of Kentucky
  • The Ochsner Clinic
  • Louisiana State University Health Science Center
  • University of Missouri / Ellis Fischel Cancer Center
  • The Center for Cancer Care & Research
  • Hematology Oncology Centers of the Northern Rockies
  • V.A. Sierra Nevada Health Care
  • Dartmouth-Hitchcock Medical Center Hematology/Oncology
  • Mt. Sinai Medical Center
  • Southeastern Medical Oncology Center
  • Providence Portland Medical Center
  • Consultants in Medical Oncology & Hematology
  • South Carolina Oncology Associates, PA
  • The West Clinic
  • Vanderbilt University Medical Center
  • Southwest Regional Cancer Center
  • Tom Baker Cancer Center
  • Princess Margaret Hospital

Outcomes

Primary Outcome Measures

Efficacy and safety (outcomes will be measured approximately 1 year after the last subject has been treated)

Secondary Outcome Measures

Full Information

First Posted
June 29, 2005
Last Updated
January 19, 2009
Sponsor
Poniard Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00116610
Brief Title
Picoplatin as Second-Line Therapy for Patients With Small Cell Lung Cancer
Official Title
A Phase II Study of Picoplatin as Second-Line Therapy for Subjects With Resistant or Refractory Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Poniard Pharmaceuticals

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
small cell lung cancer, resistant, refractory, platinum, chemotherapy, second-line, relapse, sensitive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
picoplatin
Primary Outcome Measure Information:
Title
Efficacy and safety (outcomes will be measured approximately 1 year after the last subject has been treated)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main inclusion criteria: 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.] Exclusion Criteria: 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). [Additional exclusion criteria apply.]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hazel Breitz, MD
Organizational Affiliation
Poniard Pharmaceuticals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Paul Weiden, MD
Organizational Affiliation
Poniard Pharmaceuticals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David Karlin, MD
Organizational Affiliation
Poniard Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Genesis Cancer Center
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Study Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Comprehensive Cancer Center
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Eastern Connecticut Hematology/Oncology
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Oncology Hematology Group of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Augusta Oncology Associates
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901-5104
Country
United States
Facility Name
Central Georgia Hematology Oncology Associates
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Georgia Cancer Specialists
City
Tucker
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States
Facility Name
Rush Medical College
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3828
Country
United States
Facility Name
Medical Center of Vincennes
City
Vincennes
State/Province
Indiana
ZIP/Postal Code
47591
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Markey Cancer Center, University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
The Ochsner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121-2483
Country
United States
Facility Name
Louisiana State University Health Science Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
University of Missouri / Ellis Fischel Cancer Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203-3299
Country
United States
Facility Name
The Center for Cancer Care & Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Hematology Oncology Centers of the Northern Rockies
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
V.A. Sierra Nevada Health Care
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center Hematology/Oncology
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Mt. Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Southeastern Medical Oncology Center
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534-9479
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Consultants in Medical Oncology & Hematology
City
Drexel Hill
State/Province
Pennsylvania
ZIP/Postal Code
19026
Country
United States
Facility Name
South Carolina Oncology Associates, PA
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29210
Country
United States
Facility Name
The West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6307
Country
United States
Facility Name
Southwest Regional Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Tom Baker Cancer Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
City
Stepanovskoye, Krasnogorskiy District
State/Province
Moscow Region
Country
Russian Federation
City
Ufa
State/Province
Republic of Bashkortostan
Country
Russian Federation
City
Petrozavodsk
State/Province
Republic of Karelia
Country
Russian Federation
City
Kazan
State/Province
Republic of Tatarstan
Country
Russian Federation
City
Izhevsk
State/Province
Republic of Udmurtia
Country
Russian Federation
City
Engels
State/Province
Saratov Region
Country
Russian Federation
City
Cherepovets
State/Province
Vologodskaya Region
Country
Russian Federation
City
Astrakhan
Country
Russian Federation
City
Barnaul
Country
Russian Federation
City
Chelyabinsk
Country
Russian Federation
City
Ekaterinburg
Country
Russian Federation
City
Kaliningrad
Country
Russian Federation
City
Krasnodar
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Nizhny Novgorod
Country
Russian Federation
City
Omsk
Country
Russian Federation
City
Orenburg
Country
Russian Federation
City
Pyatigorsk
Country
Russian Federation
City
Rostov-na-Donu
Country
Russian Federation
City
Samara
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation
City
Stavropol
Country
Russian Federation
City
Ulyanovsk
Country
Russian Federation
City
Voronezh
Country
Russian Federation
City
Yaroslavl
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
12671715
Citation
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.
Results Reference
background
PubMed Identifier
12645909
Citation
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.
Results Reference
background
PubMed Identifier
15205207
Citation
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.
Results Reference
background
PubMed Identifier
12649098
Citation
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.
Results Reference
background
PubMed Identifier
12647701
Citation
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.
Results Reference
background
PubMed Identifier
12645907
Citation
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.
Results Reference
background
PubMed Identifier
12367792
Citation
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.
Results Reference
background
PubMed Identifier
12781432
Citation
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.
Results Reference
background
PubMed Identifier
12679731
Citation
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.
Results Reference
background
PubMed Identifier
12645906
Citation
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.
Results Reference
background
PubMed Identifier
15161002
Citation
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.
Results Reference
background
PubMed Identifier
12441268
Citation
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.
Results Reference
background
PubMed Identifier
12827291
Citation
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.
Results Reference
background
PubMed Identifier
15292710
Citation
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.
Results Reference
background
PubMed Identifier
12645908
Citation
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.
Results Reference
background
PubMed Identifier
12460786
Citation
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.
Results Reference
background
Links:
URL
http://www.poniard.com
Description
Poniard Pharmaceuticals website
URL
http://www.centerwatch.com/
Description
CenterWatch clinical trials listings

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Picoplatin as Second-Line Therapy for Patients With Small Cell Lung Cancer

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