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

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.

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: picoplatin

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 Type: Interventional
• Enrollment: 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Center
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital
• Russian Federation
  • Astrakhan, Russian Federation
  • Barnaul, Russian Federation
  • Chelyabinsk, Russian Federation
  • Ekaterinburg, Russian Federation
  • Kaliningrad, Russian Federation
  • Krasnodar, Russian Federation
  • Moscow, Russian Federation
  • Nizhny Novgorod, Russian Federation
  • Omsk, Russian Federation
  • Orenburg, Russian Federation
  • Pyatigorsk, Russian Federation
  • Rostov-na-Donu, Russian Federation
  • Samara, Russian Federation
  • St. Petersburg, Russian Federation
  • Stavropol, Russian Federation
  • Ulyanovsk, Russian Federation
  • Voronezh, Russian Federation
  • Yaroslavl, Russian Federation
  • Moscow Region
    • Stepanovskoye, Krasnogorskiy District, Moscow Region, Russian Federation
  • Republic of Bashkortostan
    • Ufa, Republic of Bashkortostan, Russian Federation
  • Republic of Karelia
    • Petrozavodsk, Republic of Karelia, Russian Federation
  • Republic of Tatarstan
    • Kazan, Republic of Tatarstan, Russian Federation
  • Republic of Udmurtia
    • Izhevsk, Republic of Udmurtia, Russian Federation
  • Saratov Region
    • Engels, Saratov Region, Russian Federation
  • Vologodskaya Region
    • Cherepovets, Vologodskaya Region, Russian Federation
• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Genesis Cancer Center
  • California
    • Los Angeles, California, United States
      • Study Site
    • Palm Springs, California, United States, 92262
      • Comprehensive Cancer Center
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Eastern Connecticut Hematology/Oncology
  • Florida
    • Miami, Florida, United States, 33176
      • Oncology Hematology Group of South Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center
  • Georgia
    • Augusta, Georgia, United States, 30901-5104
      • Augusta Oncology Associates
    • Macon, Georgia, United States, 31201
      • Central Georgia Hematology Oncology Associates
    • Tucker, Georgia, United States, 30084
      • Georgia Cancer Specialists
  • Illinois
    • Chicago, Illinois, United States, 60612-3828
      • Rush Medical College
  • Indiana
    • Vincennes, Indiana, United States, 47591
      • Medical Center of Vincennes
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Markey Cancer Center, University of Kentucky
  • Louisiana
    • New Orleans, Louisiana, United States, 70121-2483
      • The Ochsner Clinic
    • Shreveport, Louisiana, United States, 71130-3932
      • Louisiana State University Health Science Center
  • Missouri
    • Columbia, Missouri, United States, 65203-3299
      • University of Missouri / Ellis Fischel Cancer Center
    • St. Louis, Missouri, United States, 63141
      • The Center for Cancer Care & Research
  • Montana
    • Billings, Montana, United States, 59101
      • Hematology Oncology Centers of the Northern Rockies
  • Nevada
    • Reno, Nevada, United States, 89502
      • V.A. Sierra Nevada Health Care
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center Hematology/Oncology
  • New York
    • New York, New York, United States, 10029
      • Mt. Sinai Medical Center
  • North Carolina
    • Goldsboro, North Carolina, United States, 27534-9479
      • Southeastern Medical Oncology Center
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
  • Pennsylvania
    • Drexel Hill, Pennsylvania, United States, 19026
      • Consultants in Medical Oncology & Hematology
  • South Carolina
    • Columbia, South Carolina, United States, 29210
      • South Carolina Oncology Associates, PA
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • The West Clinic
    • Nashville, Tennessee, United States, 37232-6307
      • Vanderbilt University Medical Center
  • Texas
    • Austin, Texas, United States, 78705
      • Southwest Regional Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Main inclusion criteria:

1. Diagnosis of small cell lung cancer.
2. 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.]

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Poniard Pharmaceuticals
• Investigators: Study Director: Hazel Breitz, MD, Poniard Pharmaceuticals; Study Director: Paul Weiden, MD, Poniard Pharmaceuticals; Study Director: David Karlin, MD, Poniard Pharmaceuticals

Publications and helpful links

General 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. doi: 10.1038/sj.bjc.6600854.
• 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.
• 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. 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Poniard Pharmaceuticals website
• CenterWatch clinical trials listings

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): March 1, 2007
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: June 29, 2005
• First Submitted That Met QC Criteria: June 29, 2005
• First Posted (Estimate): June 30, 2005

Study Record Updates

• Last Update Posted (Estimate): January 21, 2009
• Last Update Submitted That Met QC Criteria: January 19, 2009
• Last Verified: February 1, 2007

More Information

Terms related to this study

• Keywords: chemotherapy; relapse; refractory; resistant; small cell lung cancer; platinum; second-line; sensitive
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: 0402; IND No. 69,507