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

Small Cell Lung Cancer Clinical Trial

Official title:

A Phase II Study of Picoplatin as Second-Line Therapy for Subjects With Resistant or Refractory Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116610
• Other study ID #: 0402
• Secondary ID: IND No. 69,507
• Status: Completed
• Phase: Phase 2
• First received: June 29, 2005
• Last updated: January 19, 2009
• Start date: June 2005
• Est. completion date: March 2008

Study information

• Verified date: February 2007
• Source: Poniard Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 2008
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• picoplatin

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Center	Calgary	Alberta
Canada	Princess Margaret Hospital	Toronto	Ontario
United States	Augusta Oncology Associates	Augusta	Georgia
United States	Southwest Regional Cancer Center	Austin	Texas
United States	Hematology Oncology Centers of the Northern Rockies	Billings	Montana
United States	Rush Medical College	Chicago	Illinois
United States	South Carolina Oncology Associates, PA	Columbia	South Carolina
United States	University of Missouri / Ellis Fischel Cancer Center	Columbia	Missouri
United States	Consultants in Medical Oncology & Hematology	Drexel Hill	Pennsylvania
United States	Southeastern Medical Oncology Center	Goldsboro	North Carolina
United States	Genesis Cancer Center	Hot Springs	Arkansas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Dartmouth-Hitchcock Medical Center Hematology/Oncology	Lebanon	New Hampshire
United States	Markey Cancer Center, University of Kentucky	Lexington	Kentucky
United States	Study Site	Los Angeles	California
United States	Central Georgia Hematology Oncology Associates	Macon	Georgia
United States	The West Clinic	Memphis	Tennessee
United States	Oncology Hematology Group of South Florida	Miami	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	The Ochsner Clinic	New Orleans	Louisiana
United States	Mt. Sinai Medical Center	New York	New York
United States	Eastern Connecticut Hematology/Oncology	Norwich	Connecticut
United States	Comprehensive Cancer Center	Palm Springs	California
United States	Providence Portland Medical Center	Portland	Oregon
United States	V.A. Sierra Nevada Health Care	Reno	Nevada
United States	Louisiana State University Health Science Center	Shreveport	Louisiana
United States	The Center for Cancer Care & Research	St. Louis	Missouri
United States	H. Lee Moffitt Cancer Center	Tampa	Florida
United States	Georgia Cancer Specialists	Tucker	Georgia
United States	Medical Center of Vincennes	Vincennes	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Poniard Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Russian Federation, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Epub 2003 Jun 25. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy and safety (outcomes will be measured approximately 1 year after the last subject has been treated)

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