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

Purpose

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	Intervention	Phase
Small Cell Lung Cancer	Drug: picoplatin	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Poniard Pharmaceuticals:

Primary Outcome Measures:

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

Estimated Enrollment:	75
Study Start Date:	June 2005
Study Completion Date:	March 2008
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.]

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116610

Show 55 Study Locations

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

More Information

Additional Information:

Poniard Pharmaceuticals website This link exits the ClinicalTrials.gov site

CenterWatch clinical trials listings This link exits the ClinicalTrials.gov site

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. Results of ZD0473 in platinum-pretreated ovarian cancer: analysis according to platinum free interval. Eur J Cancer. 2002 Dec;38 Suppl 8:S7-12.

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.

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.

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.

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.

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.

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.

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.

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.

ClinicalTrials.gov Identifier:	NCT00116610 History of Changes
Other Study ID Numbers:	0402, IND No. 69,507
Study First Received:	June 29, 2005
Last Updated:	January 19, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Poniard Pharmaceuticals:

small cell lung cancer
resistant
refractory
platinum

chemotherapy
second-line
relapse
sensitive

Additional relevant MeSH terms:

Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site

Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013