Study of Picoplatin Efficacy After Relapse

NCT00465491 | Unknown Phase 3 DMC

• 1 other identifier: 0601
• Study Type: interventional
• Target: 399
• Locations: 15 countries
• Sites: 143

Brief Summary

Picoplatin is a new type of platinum drug that has been investigated in several clinical trials, and may provide an improved safety profile over current treatment options. This study is designed to compare the efficacy and safety of picoplatin plus Best Supportive Care (BSC) with BSC alone. Best Supportive Care includes care and treatment to optimize the comfort of patients and their ability to function, as well as to minimize the side-effects of anti-cancer treatments.

Conditions

Small Cell Lung Cancer

Keywords

refractory; chemotherapy; progressed; second-line treatment; small cell lung cancer; best supportive care; picoplatin

Outcome Measures

Primary Outcomes (1)

• overall survival

  death

Secondary Outcomes (4)

• objective response rate

  progression

• disease control rate

  progression

• duration of response

  progression

• progression-free survival

  death

Study Arms (2)

1

EXPERIMENTAL

Picoplatin

Drug: picoplatin

2

OTHER

BSC

Other: best supportive care

Interventions

picoplatin DRUG

IV picoplatin 150mg/m2 q3wk

1

best supportive care OTHER

best supportive care

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytological diagnosis of SCLC or combined SCLC/non-small cell lung cancer (NSCLC) defined as SCLC mixed with squamous cell carcinoma, adenocarcinoma, or large cell carcinoma.
• One and only 1 prior cisplatin or carboplatin-containing chemotherapy regimen for SCLC within the scope of the National Comprehensive Cancer Network (NCCN) Guidelines (Section 5.4.1).
• Radiological evidence of SCLC that never responded or progressed within 90 days after completion of first-line therapy (refractory); or responded initially to first-line therapy but progressed between 91 and 180 days after treatment was completed (progressed within 91 to 180 days).
• CT scans of head, chest and abdomen (including adrenal and full extent of liver) with contrast, preferably within 14 days prior to randomization (up to 21 days is allowed if necessary). MRI is acceptable in the case of allergy to contrast agents. The presence or absence of measurable disease gy RECIST must be documented from the baseline CT or MRI scan.
• Patients with brain metastases must have been treated with brain irradiation. Only patients wtih asymptomatic brain metastases are eligible for this study.
• ECOG PS 0, 1 or 2 within 3 days prior to randomization (Appendix II).
• Life expectancy of at least 8 weeks within 3 days prior to randomization.
• At least 21 days must have elapsed since the most recent prior chemotherapy dose, with evidence of hematological recovery.
• At least 14 days must have elapsed since the most recent prior radiotherapy dose.
• At least 14 days must have elapsed since prior surgery except for the placement of venous access device or bronchoscopy.
• Subject must be recovered to ≤ Grade 1 toxicity from all non-hematological adverse effects of prior therapies (excluding alopecia).
• Age 18 years or over.
• ANC ≥ 1.5 x 109/L.
• Platelet count ≥ 100 x 109/L.
• Hemoglobin of ≥ 90 g/L (transfusion permitted to achieve this hemoglobin).

You may not qualify if:

• Prior radiotherapy that included ≥ 30% of the bone marrow (Appendix IV).
• Pleural effusion as the only radiological evidence of SCLC.
• Untreated or symptomatic brain or central nervous system (CNS) metastases.
• Grade 2 or higher peripheral neuropathy.
• Significant cardiac disease, defined as myocardial infarction within 3 months prior to randomization, congestive heart failure classified by the New York Heart Association as Class III or IV (Appendix V), uncontrolled cardiac arrhythmias, poorly controlled or unstable angina, or electrocardiographic evidence of acute ischemia.
• Serious medical or psychiatric illness that could potentially interfere with the completion of study treatment according to this protocol, e.g., active infection, Crohn's disease, ulcerative colitis, etc.
• Use of other investigational drugs within 30 days prior to randomization.
• Breast-feeding.
• History of any other malignancy within 5 years, with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix.

Sponsors & Collaborators

• Poniard Pharmaceuticals: lead

Study Sites (143)

Consultorios Privados

Buenos Aires, B1704ESN, Argentina

Location

Clinica Constituyentes

Buenos Aires, B1708KCH, Argentina

Location

CETEN Centro de Estudio y Tratamiento de Enfermedades Neoplasicas

Buenos Aires, B1874ACL, Argentina

Location

IADT (Insttituto Argentino de Diagnostico y Tratamiento S.A.)

Buenos Aires, C1122AAL, Argentina

Location

Centro Oncologico

Buenos Aires, C1212ACA, Argentina

Location

Instituto Alexander Fleming

Buenos Aires, C1426ANZ, Argentina

Location

PALIAR

Buenos Aires, C1430ERF, Argentina

Location

IONC

Córdoba, X5000AAI, Argentina

Location

Centro Medico San Roque

San Miguel de Tucumán, T4000IAA, Argentina

Location

Centro Oncologico de Rosario

Santa Fe, S2000DSK, Argentina

Location

ISIS Clinica Especializada

Santa Fe, S3002EKI, Argentina

Location

Institution of Healthcare "Grodno Regional Clinical Hospital

Grodno, 230017, Belarus

Location

Gomel Regional Oncological Dispensary

Homyel, 246012, Belarus

Location

Minsk City Clinical Oncology Dispensary

Minsk, 220013, Belarus

Location

Research Institute of Oncology and Medical Radiology named by N.N. Aleksandrov

Minsk, 223040, Belarus

Location

Vitebsk Regional Oncology Dispensary

Vitebsk, 210603, Belarus

Location

Clinic for Lung Diseases, Clinical Center, Banja Luka

Banja Luka, 78000, Bosnia and Herzegovina

Location

Clinic of Pulmonary Diseases Podhrastovi

Sarajevo, Bosnia and Herzegovina

Location

Multiprofile Hospital for Active Treatment, Dr. Tota Venkova

Gabrovo, 5300, Bulgaria

Location

University Multifunctional Hospital for Active Treatment "Dr. Georgi Stranski"

Pleven, 5800, Bulgaria

Location

District Dispensary for Cancer Diseases with Inpatient Hospital Plovdiv

Plovdiv, 4004, Bulgaria

Location

Regional Oncodispensary with Inpatient Sector

Rousse, 7000, Bulgaria

Location

Inter-district Dispensary for Cancer Diseases w/Inpatient Hospital

Shumen, 9700, Bulgaria

Location

Regional Oncodispensary with Inpatient Sector-Sofia District

Sofia, 1233, Bulgaria

Location

Inter-district Dispensary for Cancer Disease w/Inpatient Hospital "Dr. Marko Markov", Varna

Varna, 9010, Bulgaria

Location

Multiprofile Hospital for Active Treatment "St. Marina"

Varna, 9010, Bulgaria

Location

Instituto Nacional de Cancer

Santiago, 2363058, Chile

Location

Clinical Hospital

Dubrovnik, Croatia

Location

Clinical Hospital

Osijek, 31000, Croatia

Location

Clinical Hospital Split

Split, 2001, Croatia

Location

Clinic for Pulmonary Diseses "Jordanovac"

Zagreb, Croatia

Location

St. George County Hospital

Fejer County, 8000, Hungary

Location

University of Szeged

Szeged, 6772, Hungary

Location

General Rehablitation and Medicinal Bath Hospital

Szombathely, 9700, Hungary

Location

Gujrat Cancer Research Institute

Asarwa, Ahmadabad, 380016, India

Location

Kidwai Memorial Institute of Oncology

Bangalore, Karnataka, 560029, India

Location

Lakeshore Hospital and Research Center

Kochi, Kerala, 682304, India

Location

Shatabdi Superspeciality Hospital

Nashik, Maharashtra, 422005, India

Location

Curie Centre of Oncology

Bangalore, 560034, India

Location

Jawaharlal Nehru Cancer Hospital and Research Centre

Bhopal, India

Location

Apollo Speciality Hospital

Chennai, 600035, India

Location

MNJ Institute of Oncology

Hyderabaad, 500004, India

Location

Indo American Institute of Oncology

Hyderabaad, 500034, India

Location

Yashoda Group of Hospitals

Hyderabad, 500082, India

Location

SEAROC Cancer Center

Jaipur, 302013, India

Location

Institute of Post Graduate Medical Education and Research

Kolkata, 700020, India

Location

Orchid Nursing Home

Kolkata, 700054, India

Location

King George Medical University

Lucknow, India

Location

KMC (Karturba Medical College) Hospital

Manipal, India

Location

Jaslok Hospital and Research Centre

Mumbai, 400026, India

Location

Tata Memorial Centre

Mumbai, India

Location

Sir Ganga Ram Hospital

New Delhi, 110060, India

Location

Rajiv Gandhi Cancer Institute, Delhi

New Delhi, 110085, India

Location

Mahaveer Cancer Sansthan

Patna, 801505, India

Location

Jahangir Hospital and Research Centre

Pune, 411001, India

Location

Smt. Vasantben R. Desai Cancer Research Center

Rajkot, 360007, India

Location

Regional Cancer Centre

Trivandrum, 695011, India

Location

King George Hospital

Visakhapatnam, India

Location

Daugavas Hospital

Daugavpils, 5420, Latvia

Location

Paul Stradins Clincial University Hospital

Riga, 1002, Latvia

Location

Special Hospital for Pulmonary Diseases

Nikšić, 81400, Montenegro

Location

Silesian Medical University in Katowice

Zabrze, Dolny Slask, 41-803, Poland

Location

Dolnoslaskie Centre of Lung Diseases

Wroclaw, Lower Silesian Voivodeship, 53-439, Poland

Location

Kujawsko-Pomorski Centre of Pulmonology

Bydgoszcz, 85-326, Poland

Location

NMP, Memorial Voyvodship Hospital

Częstochowa, 42200, Poland

Location

Dr. Bieganski Memorial Regional Specialsitic Hospital

Grudziądz, 86-300, Poland

Location

Regional Hospital, Department of Pulmonary Diseases and Chemotherapy

Krakow, 31202, Poland

Location

Independent Public Group for Tuberculosis and Lung Disease in Olsztyn

Olsztyn, 10-357, Poland

Location

Department of Clinical Oncology, Wielkopolskie Centre of Lung Diseases and Tuberculosis

Poznan, 60-569, Poland

Location

Conservative Outpatient Oncology Department, Voyevodship Hospital in Plock

Płock, 09-400, Poland

Location

Department of Pulmonology, Voyvodship Specialsitic Hospital in Radom

Radom, 26-617, Poland

Location

SP ZOZ Voyevodship Specialistic Hospital #3

Rybnik, 44-200, Poland

Location

Department of Chemotherapy, Prof. A. Sokolowski Memorial Specialistic Hospital in Szczecin

Szczecin, 70-891, Poland

Location

Department of Clinical Oncology, SP ZOZ, Yoyvodship Specialistic Hospital

Torun, 87-100, Poland

Location

Prof. Dr. Ion Chiricuta, Institute of Oncology Cluj-Napoca

Cluj-Napoca, Cluj, 400015, Romania

Location

Baia Mare "Constantin Opris" County Emergency Hospital

Baia Mare, Maramureş, 4800, Romania

Location

IANULI Medconsult SRL

Bucharest, 020962, Romania

Location

Bucharest Institute of Oncology

Bucharest, 022328, Romania

Location

Prof. Dr. Ion Chircuta, Oncology Institute

Cluj-Napoca, 400015, Romania

Location

Clinical Emergency County Hospital Constanta

Constanța, 900591, Romania

Location

Medical Oncology Center Iasi

Iași, 700106, Romania

Location

Schuller Municipal Hospital Ploiesti-Medical Oncology Department

Ploieşti, 100337, Romania

Location

Clinical County Hospital

Sibiu, 550245, Romania

Location

Sf. loan cel Nou, Emergency County Hospital

Suceava, Romania

Location

OncoMed

Timișoara, 300239, Romania

Location

Buryatia Republican Oncology Center

Ulan-Ude, Buryatiya Republic, 670047, Russia

Location

Regional Oncology Center

Birobidzhan, Jewish Republic, 679016, Russia

Location

Republican Oncology Center of the Ministry of Healthcare of Karelia Republic

Petrozavodsk, Karelia Republic, 185007, Russia

Location

Komi Republican Oncology Center

Syktyvkar, Komi, 167904, Russia

Location

Clinical Oncology Center

Kazan', Tatarstan Republic, 420029, Russia

Location

Kazan Oncology Center

Kazan', Tatarstan Republic, 420111, Russia

Location

Arkhangelsk Regional Clinical Oncology Center

Arkhangelsk, 163045, Russia

Location

Altai Regional Oncology Center

Barnaul, 656049, Russia

Location

Chelyabinsk Regional Oncology Center

Chelyabinsk, 454087, Russia

Location

City Hospital #1

Cherepovets, 162627, Russia

Location

Chita Regional Oncology Center

Chita, 672027, Russia

Location

Regional Oncology Center

Engel's, 413115, Russia

Location

Regional Oncology Center

Irkutsk, 664035, Russia

Location

Ivanovo Regional Oncology Center

Ivanovo, 214000, Russia

Location

Republican Clinical Oncology Center of the Republic of Udmurtia

Izhevsk, 426009, Russia

Location

Kaluga Regional Oncology Center

Kaluga, 248007, Russia

Location

Regional Clinical Oncology Center

Khabarovsk, 680042, Russia

Location

Regional Clinical Oncology Center

Kirov, 610021, Russia

Location

City Oncology Center

Komsomolsk-on-Amur, 681000, Russia

Location

Krasnodar Clinical Oncology

Krasnodar, 350040, Russia

Location

Regional Clinical Hospital #1

Krasnodar, 350086, Russia

Location

Kurst Regional Oncology Center

Kurst, Russia

Location

Lipetsk Regional Oncology Center

Lipetsk, 398005, Russia

Location

Magnitogorsk Clinical Oncology Hospital

Magnitogorsk, 455001, Russia

Location

Blokhin Russian Oncology Research Center

Moscow, 115478, Russia

Location

Central Clinical Hospital and Outpatient Unit of the Medical Center under the Russian Presidential Administration

Moscow, 121359, Russia

Location

Semashko Central Clinical Hospital #2 under Russian Railways

Moscow, 129128, Russia

Location

Novorossiysk Oncology Center

Novorossiysk, 353915, Russia

Location

City Clinical Hospital #1

Novosibirsk, 630047, Russia

Location

Medical Radiology Research Center under RAMS

Obnninsk, 249036, Russia

Location

Orenburg Regional Clinical Oncology Center

Orenburg, 460021, Russia

Location

Orel Oncology Center

Oryol, 302020, Russia

Location

Regional Oncology Center

Penza, 440071, Russia

Location

Pyatigorsk Affiliate of Stavropol Regional Clinical Oncology Center

Pyatigorsk, 357502, Russia

Location

St. Petersburg City Multifield Hospital #2

Saint Petersburg, 194354, Russia

Location

St. Petersburg Pavlov State Medical University

Saint Petersburg, 197022, Russia

Location

Pavlov St. Petersburg State Medical University, Pulmonology Research Institute

Saint Petersburg, 197101, Russia

Location

City Clinical Oncology Center, Thoracic Oncology Department #6

Saint Petersburg, 198255, Russia

Location

Ogarev Mordovian State University

Saransk, 430032, Russia

Location

State Higher Education Institution Saratov State Medical University under the Federal Agency for Healthcare and Social Development

Saratov, 410012, Russia

Location

Oncology Center

Sochi, 354057, Russia

Location

Tambov Regional Oncology Center

Tambov, 390013, Russia

Location

Tomsk Regional Oncology Center

Tomsk, 634050, Russia

Location

Tula Regional Oncology Center

Tula, 300040, Russia

Location

Ufa, Republican Oncology Center

Ufa, Russia

Location

Primorsky Regional Oncology Center

Vladivostok, 690105, Russia

Location

Volgograd Regional Clinical Oncology Center#1

Volograd, 400138, Russia

Location

Voronezh Regional Clinical Oncology Center

Voronezh, 394000, Russia

Location

Regional Clinical Oncology Hospital

Yaroslavl, 150054, Russia

Location

Sverdlovsk Regional Oncology Center

Yekaterinburg, 620036, Russia

Location

Republican of Clinical Hospital, Mariy-El Republican

Yoshkar-Ola, 424037, Russia

Location

Clinic for Pulmonary Diseases and TBC

Knez-Selo, Serbia

Location

Institute for Pulmonary Diseases of Vijvodina

Vijvodina, Serbia

Location

Volyn Regional Oncology Center

Lutsk, 43018, Ukraine

Location

Public Treatment and Prevention Institution Mariupol City Interdistrict Oncology Center

Mariupol, 87500, Ukraine

Location

Sumy Regional Oncology Center

Sumy, 40005, Ukraine

Location

Ternopol Regional Clinical Oncology Center

Ternopil, 46023, Ukraine

Location

Zaporozhye Regional Clinical Oncology Center

Zaporizhzhya, 69040, Ukraine

Location

Related Publications (10)

• Raynaud FI, Boxall FE, Goddard PM, Valenti M, Jones M, Murrer BA, Abrams M, Kelland LR. cis-Amminedichloro(2-methylpyridine) platinum(II) (AMD473), a novel sterically hindered platinum complex: in vivo activity, toxicology, and pharmacokinetics in mice. Clin Cancer Res. 1997 Nov;3(11):2063-74.

  PMID: 9815598 BACKGROUND

• 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.

  PMID: 12671715 BACKGROUND

• 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.

  PMID: 12647701 BACKGROUND

• 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.

  PMID: 12645908 BACKGROUND

• 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.

  PMID: 12645907 BACKGROUND

• Holford J, Raynaud F, Murrer BA, Grimaldi K, Hartley JA, Abrams M, Kelland LR. Chemical, biochemical and pharmacological activity of the novel sterically hindered platinum co-ordination complex, cis-[amminedichloro(2-methylpyridine)] platinum(II) (AMD473). Anticancer Drug Des. 1998 Jan;13(1):1-18.

  PMID: 9474239 BACKGROUND

• Holford J, Sharp SY, Murrer BA, Abrams M, Kelland LR. In vitro circumvention of cisplatin resistance by the novel sterically hindered platinum complex AMD473. Br J Cancer. 1998;77(3):366-73. doi: 10.1038/bjc.1998.59.

  PMID: 9472630 BACKGROUND

• Rogers P, Boxall FE, Allott CP, Stephens TC, Kelland LR. Sequence-dependent synergism between the new generation platinum agent ZD0473 and paclitaxel in cisplatin-sensitive and -resistant human ovarian carcinoma cell lines. Eur J Cancer. 2002 Aug;38(12):1653-60. doi: 10.1016/s0959-8049(02)00107-7.

  PMID: 12142057 BACKGROUND

• 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.

  PMID: 12441268 BACKGROUND

• 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.

  PMID: 12367792 BACKGROUND

Related Links

• Poniard Pharmaceuticals, Inc.

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

amminedichloro(2-methylpyridine)platinum(II)

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dr. Hazel Breitz, M.D.

  Poniard Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 25, 2007
• Study Start: April 1, 2007
• Primary Completion: May 1, 2009
• Last Updated: April 14, 2009

Record last verified: 2009-04

Locations

CR (4); UA (5); RU (51); SE (2); IN (24); BU (8); BO (2); BE (5); LA (2); PL (13); MO (1); HU (3); RO (11); AR (11); CL (1)