Picoplatin as Second-Line Therapy for Patients With Small Cell Lung Cancer
Sponsor
Poniard Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00116610
Collaborator
(none)
75
55
33
1.4
0
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
Study Design
Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Picoplatin as Second-Line Therapy for Subjects With Resistant or Refractory Small Cell Lung Cancer
Study Start Date
:
Jun 1, 2005
Actual Primary Completion Date
:
Mar 1, 2007
Actual Study Completion Date
:
Mar 1, 2008
Outcome Measures
Primary Outcome Measures
- Efficacy and safety (outcomes will be measured approximately 1 year after the last subject has been treated) []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.]
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Genesis Cancer Center | Hot Springs | Arkansas | United States | 71913 |
| 2 | Study Site | Los Angeles | California | United States | |
| 3 | Comprehensive Cancer Center | Palm Springs | California | United States | 92262 |
| 4 | Eastern Connecticut Hematology/Oncology | Norwich | Connecticut | United States | 06360 |
| 5 | Oncology Hematology Group of South Florida | Miami | Florida | United States | 33176 |
| 6 | H. Lee Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
| 7 | Augusta Oncology Associates | Augusta | Georgia | United States | 30901-5104 |
| 8 | Central Georgia Hematology Oncology Associates | Macon | Georgia | United States | 31201 |
| 9 | Georgia Cancer Specialists | Tucker | Georgia | United States | 30084 |
| 10 | Rush Medical College | Chicago | Illinois | United States | 60612-3828 |
| 11 | Medical Center of Vincennes | Vincennes | Indiana | United States | 47591 |
| 12 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
| 13 | Markey Cancer Center, University of Kentucky | Lexington | Kentucky | United States | 40536 |
| 14 | The Ochsner Clinic | New Orleans | Louisiana | United States | 70121-2483 |
| 15 | Louisiana State University Health Science Center | Shreveport | Louisiana | United States | 71130-3932 |
| 16 | University of Missouri / Ellis Fischel Cancer Center | Columbia | Missouri | United States | 65203-3299 |
| 17 | The Center for Cancer Care & Research | St. Louis | Missouri | United States | 63141 |
| 18 | Hematology Oncology Centers of the Northern Rockies | Billings | Montana | United States | 59101 |
| 19 | V.A. Sierra Nevada Health Care | Reno | Nevada | United States | 89502 |
| 20 | Dartmouth-Hitchcock Medical Center Hematology/Oncology | Lebanon | New Hampshire | United States | 03756 |
| 21 | Mt. Sinai Medical Center | New York | New York | United States | 10029 |
| 22 | Southeastern Medical Oncology Center | Goldsboro | North Carolina | United States | 27534-9479 |
| 23 | Providence Portland Medical Center | Portland | Oregon | United States | 97213 |
| 24 | Consultants in Medical Oncology & Hematology | Drexel Hill | Pennsylvania | United States | 19026 |
| 25 | South Carolina Oncology Associates, PA | Columbia | South Carolina | United States | 29210 |
| 26 | The West Clinic | Memphis | Tennessee | United States | 38120 |
| 27 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232-6307 |
| 28 | Southwest Regional Cancer Center | Austin | Texas | United States | 78705 |
| 29 | Tom Baker Cancer Center | Calgary | Alberta | Canada | T2N 4N2 |
| 30 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
| 31 | Stepanovskoye, Krasnogorskiy District | Moscow Region | Russian Federation | ||
| 32 | Ufa | Republic of Bashkortostan | Russian Federation | ||
| 33 | Petrozavodsk | Republic of Karelia | Russian Federation | ||
| 34 | Kazan | Republic of Tatarstan | Russian Federation | ||
| 35 | Izhevsk | Republic of Udmurtia | Russian Federation | ||
| 36 | Engels | Saratov Region | Russian Federation | ||
| 37 | Cherepovets | Vologodskaya Region | Russian Federation | ||
| 38 | Astrakhan | Russian Federation | |||
| 39 | Barnaul | Russian Federation | |||
| 40 | Chelyabinsk | Russian Federation | |||
| 41 | Ekaterinburg | Russian Federation | |||
| 42 | Kaliningrad | Russian Federation | |||
| 43 | Krasnodar | Russian Federation | |||
| 44 | Moscow | Russian Federation | |||
| 45 | Nizhny Novgorod | Russian Federation | |||
| 46 | Omsk | Russian Federation | |||
| 47 | Orenburg | Russian Federation | |||
| 48 | Pyatigorsk | Russian Federation | |||
| 49 | Rostov-na-Donu | Russian Federation | |||
| 50 | Samara | Russian Federation | |||
| 51 | St. Petersburg | Russian Federation | |||
| 52 | Stavropol | Russian Federation | |||
| 53 | Ulyanovsk | Russian Federation | |||
| 54 | Voronezh | Russian Federation | |||
| 55 | Yaroslavl | Russian Federation |
Sponsors and Collaborators
- Poniard Pharmaceuticals
Investigators
- Study Director: Hazel Breitz, MD, Poniard Pharmaceuticals
- Study Director: Paul Weiden, MD, Poniard Pharmaceuticals
- Study Director: David Karlin, MD, Poniard Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Epub 2003 Jun 25.
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00116610
Other Study ID Numbers:
- 0402
- IND No. 69,507
First Posted:
Jun 30, 2005
Last Update Posted:
Jan 21, 2009
Last Verified:
Feb 1, 2007
Keywords provided by ,
,
Additional relevant MeSH terms: