Clinical trial NCT00116610: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Keywords: small cell lung cancer
resistant
refractory
platinum
chemotherapy
second-line
relapse
sensitive
Lead sponsor: Poniard Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-06-30
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

\[Additional exclusion criteria apply.\]

Primary outcomes:
measure: Efficacy and safety (outcomes will be measured approximately 1 year after the last subject has been treated)
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Los Angeles
country: United States
facility: Study Site
state: California
city: Palm Springs
country: United States
facility: Comprehensive Cancer Center
state: California
city: Norwich
country: United States
facility: Eastern Connecticut Hematology/Oncology
state: Connecticut
city: Miami
country: United States
facility: Oncology Hematology Group of South Florida
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Augusta
country: United States
facility: Augusta Oncology Associates
state: Georgia
city: Macon
country: United States
facility: Central Georgia Hematology Oncology Associates
state: Georgia
city: Tucker
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Chicago
country: United States
facility: Rush Medical College
state: Illinois
city: Vincennes
country: United States
facility: Medical Center of Vincennes
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: Markey Cancer Center, University of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: The Ochsner Clinic
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State University Health Science Center
state: Louisiana
city: Columbia
country: United States
facility: University of Missouri / Ellis Fischel Cancer Center
state: Missouri
city: St. Louis
country: United States
facility: The Center for Cancer Care & Research
state: Missouri
city: Billings
country: United States
facility: Hematology Oncology Centers of the Northern Rockies
state: Montana
city: Reno
country: United States
facility: V.A. Sierra Nevada Health Care
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center Hematology/Oncology
state: New Hampshire
city: New York
country: United States
facility: Mt. Sinai Medical Center
state: New York
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center
state: North Carolina
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Drexel Hill
country: United States
facility: Consultants in Medical Oncology & Hematology
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina Oncology Associates, PA
state: South Carolina
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Southwest Regional Cancer Center
state: Texas
city: Calgary
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Stepanovskoye, Krasnogorskiy District
country: Russian Federation
state: Moscow Region
city: Ufa
country: Russian Federation
state: Republic of Bashkortostan
city: Petrozavodsk
country: Russian Federation
state: Republic of Karelia
city: Kazan
country: Russian Federation
state: Republic of Tatarstan
city: Izhevsk
country: Russian Federation
state: Republic of Udmurtia
city: Engels
country: Russian Federation
state: Saratov Region
city: Cherepovets
country: Russian Federation
state: Vologodskaya Region
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
Study officials:
affiliation: Poniard Pharmaceuticals
name: Hazel Breitz, MD
role: STUDY_DIRECTOR
affiliation: Poniard Pharmaceuticals
name: Paul Weiden, MD
role: STUDY_DIRECTOR
affiliation: Poniard Pharmaceuticals
name: David Karlin, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.