Study Results
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Basic Information
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UNKNOWN
PHASE3
399 participants
INTERVENTIONAL
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Picoplatin
picoplatin
IV picoplatin 150mg/m2 q3wk
2
BSC
best supportive care
best supportive care
Interventions
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picoplatin
IV picoplatin 150mg/m2 q3wk
best supportive care
best supportive care
Eligibility Criteria
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Inclusion Criteria
* 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).
* Aspartate aminotransferase, alanine aminotransferase, and lactate dehydrogenase levels ≤ 2.5 times upper limit of normal (ULN) or ≤ 5 times ULN if liver involvement is present.
* Bilirubin of ≤ 1.5 times upper limit of normal (ULN).
* Blood urea nitrogen ≤ 1.5 times ULN (hypovolemic subjects may be hydrated to achieve this BUN).
* Creatinine clearance of ≥ 50 mL/min, as calculated by the Cockcroft-Gault formula (Appendix III).
* Women of childbearing potential must have a negative pregnancy test (serum or urine). Sexually active couples of child-bearing potential must agree to use appropriate birth control methods during chemotherapy and for 3 months after chemotherapy.
* Signed informed consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Poniard Pharmaceuticals
INDUSTRY
Responsible Party
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Poniard Pharmaceuticals, Inc.
Principal Investigators
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Dr. Hazel Breitz, M.D.
Role: STUDY_DIRECTOR
Poniard Pharmaceuticals
Locations
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Consultorios Privados
Buenos Aires, , Argentina
Clinica Constituyentes
Buenos Aires, , Argentina
CETEN Centro de Estudio y Tratamiento de Enfermedades Neoplasicas
Buenos Aires, , Argentina
IADT (Insttituto Argentino de Diagnostico y Tratamiento S.A.)
Buenos Aires, , Argentina
Centro Oncologico
Buenos Aires, , Argentina
Instituto Alexander Fleming
Buenos Aires, , Argentina
PALIAR
Buenos Aires, , Argentina
IONC
Córdoba, , Argentina
Centro Medico San Roque
San Miguel de Tucumán, , Argentina
Centro Oncologico de Rosario
Santa Fe, , Argentina
ISIS Clinica Especializada
Santa Fe, , Argentina
Institution of Healthcare "Grodno Regional Clinical Hospital
Grodno, , Belarus
Gomel Regional Oncological Dispensary
Homyel, , Belarus
Minsk City Clinical Oncology Dispensary
Minsk, , Belarus
Research Institute of Oncology and Medical Radiology named by N.N. Aleksandrov
Minsk, , Belarus
Vitebsk Regional Oncology Dispensary
Vitebsk, , Belarus
Clinic for Lung Diseases, Clinical Center, Banja Luka
Banja Luka, , Bosnia and Herzegovina
Clinic of Pulmonary Diseases Podhrastovi
Sarajevo, , Bosnia and Herzegovina
Multiprofile Hospital for Active Treatment, Dr. Tota Venkova
Gabrovo, , Bulgaria
University Multifunctional Hospital for Active Treatment "Dr. Georgi Stranski"
Pleven, , Bulgaria
District Dispensary for Cancer Diseases with Inpatient Hospital Plovdiv
Plovdiv, , Bulgaria
Regional Oncodispensary with Inpatient Sector
Rousse, , Bulgaria
Inter-district Dispensary for Cancer Diseases w/Inpatient Hospital
Shumen, , Bulgaria
Regional Oncodispensary with Inpatient Sector-Sofia District
Sofia, , Bulgaria
Inter-district Dispensary for Cancer Disease w/Inpatient Hospital "Dr. Marko Markov", Varna
Varna, , Bulgaria
Multiprofile Hospital for Active Treatment "St. Marina"
Varna, , Bulgaria
Instituto Nacional de Cancer
Santiago, , Chile
Clinical Hospital
Dubrovnik, , Croatia
Clinical Hospital
Osijek, , Croatia
Clinical Hospital Split
Split, , Croatia
Clinic for Pulmonary Diseses "Jordanovac"
Zagreb, , Croatia
St. George County Hospital
Fejer County, , Hungary
University of Szeged
Szeged, , Hungary
General Rehablitation and Medicinal Bath Hospital
Szombathely, , Hungary
Gujrat Cancer Research Institute
Asarwa, Ahmadabad, India
Kidwai Memorial Institute of Oncology
Bangalore, Karnataka, India
Lakeshore Hospital and Research Center
Kochi, Kerala, India
Shatabdi Superspeciality Hospital
Nashik, Maharashtra, India
Curie Centre of Oncology
Bangalore, , India
Jawaharlal Nehru Cancer Hospital and Research Centre
Bhopal, , India
Apollo Speciality Hospital
Chennai, , India
MNJ Institute of Oncology
Hyderabaad, , India
Indo American Institute of Oncology
Hyderabaad, , India
Yashoda Group of Hospitals
Hyderabad, , India
SEAROC Cancer Center
Jaipur, , India
Institute of Post Graduate Medical Education and Research
Kolkata, , India
Orchid Nursing Home
Kolkata, , India
King George Medical University
Lucknow, , India
KMC (Karturba Medical College) Hospital
Manipal, , India
Jaslok Hospital and Research Centre
Mumbai, , India
Tata Memorial Centre
Mumbai, , India
Sir Ganga Ram Hospital
New Delhi, , India
Rajiv Gandhi Cancer Institute, Delhi
New Delhi, , India
Mahaveer Cancer Sansthan
Patna, , India
Jahangir Hospital and Research Centre
Pune, , India
Smt. Vasantben R. Desai Cancer Research Center
Rajkot, , India
Regional Cancer Centre
Trivandrum, , India
King George Hospital
Visakhapatnam, , India
Daugavas Hospital
Daugavpils, , Latvia
Paul Stradins Clincial University Hospital
Riga, , Latvia
Special Hospital for Pulmonary Diseases
Nikšić, , Montenegro
Silesian Medical University in Katowice
Zabrze, Dolny Slask, Poland
Dolnoslaskie Centre of Lung Diseases
Wroclaw, Lower Silesian Voivodeship, Poland
Kujawsko-Pomorski Centre of Pulmonology
Bydgoszcz, , Poland
NMP, Memorial Voyvodship Hospital
Częstochowa, , Poland
Dr. Bieganski Memorial Regional Specialsitic Hospital
Grudziądz, , Poland
Regional Hospital, Department of Pulmonary Diseases and Chemotherapy
Krakow, , Poland
Independent Public Group for Tuberculosis and Lung Disease in Olsztyn
Olsztyn, , Poland
Department of Clinical Oncology, Wielkopolskie Centre of Lung Diseases and Tuberculosis
Poznan, , Poland
Conservative Outpatient Oncology Department, Voyevodship Hospital in Plock
Płock, , Poland
Department of Pulmonology, Voyvodship Specialsitic Hospital in Radom
Radom, , Poland
SP ZOZ Voyevodship Specialistic Hospital #3
Rybnik, , Poland
Department of Chemotherapy, Prof. A. Sokolowski Memorial Specialistic Hospital in Szczecin
Szczecin, , Poland
Department of Clinical Oncology, SP ZOZ, Yoyvodship Specialistic Hospital
Torun, , Poland
Prof. Dr. Ion Chiricuta, Institute of Oncology Cluj-Napoca
Cluj-Napoca, Cluj, Romania
Baia Mare "Constantin Opris" County Emergency Hospital
Baia Mare, Maramureş, Romania
IANULI Medconsult SRL
Bucharest, , Romania
Bucharest Institute of Oncology
Bucharest, , Romania
Prof. Dr. Ion Chircuta, Oncology Institute
Cluj-Napoca, , Romania
Clinical Emergency County Hospital Constanta
Constanța, , Romania
Medical Oncology Center Iasi
Iași, , Romania
Schuller Municipal Hospital Ploiesti-Medical Oncology Department
Ploieşti, , Romania
Clinical County Hospital
Sibiu, , Romania
Sf. loan cel Nou, Emergency County Hospital
Suceava, , Romania
OncoMed
Timișoara, , Romania
Buryatia Republican Oncology Center
Ulan-Ude, Buryatiya Republic, Russia
Regional Oncology Center
Birobidzhan, Jewish Republic, Russia
Republican Oncology Center of the Ministry of Healthcare of Karelia Republic
Petrozavodsk, Karelia Republic, Russia
Komi Republican Oncology Center
Syktyvkar, Komi, Russia
Clinical Oncology Center
Kazan', Tatarstan Republic, Russia
Kazan Oncology Center
Kazan', Tatarstan Republic, Russia
Arkhangelsk Regional Clinical Oncology Center
Arkhangelsk, , Russia
Altai Regional Oncology Center
Barnaul, , Russia
Chelyabinsk Regional Oncology Center
Chelyabinsk, , Russia
City Hospital #1
Cherepovets, , Russia
Chita Regional Oncology Center
Chita, , Russia
Regional Oncology Center
Engel's, , Russia
Regional Oncology Center
Irkutsk, , Russia
Ivanovo Regional Oncology Center
Ivanovo, , Russia
Republican Clinical Oncology Center of the Republic of Udmurtia
Izhevsk, , Russia
Kaluga Regional Oncology Center
Kaluga, , Russia
Regional Clinical Oncology Center
Khabarovsk, , Russia
Regional Clinical Oncology Center
Kirov, , Russia
City Oncology Center
Komsomolsk-on-Amur, , Russia
Krasnodar Clinical Oncology
Krasnodar, , Russia
Regional Clinical Hospital #1
Krasnodar, , Russia
Kurst Regional Oncology Center
Kurst, , Russia
Lipetsk Regional Oncology Center
Lipetsk, , Russia
Magnitogorsk Clinical Oncology Hospital
Magnitogorsk, , Russia
Blokhin Russian Oncology Research Center
Moscow, , Russia
Central Clinical Hospital and Outpatient Unit of the Medical Center under the Russian Presidential Administration
Moscow, , Russia
Semashko Central Clinical Hospital #2 under Russian Railways
Moscow, , Russia
Novorossiysk Oncology Center
Novorossiysk, , Russia
City Clinical Hospital #1
Novosibirsk, , Russia
Medical Radiology Research Center under RAMS
Obnninsk, , Russia
Orenburg Regional Clinical Oncology Center
Orenburg, , Russia
Orel Oncology Center
Oryol, , Russia
Regional Oncology Center
Penza, , Russia
Pyatigorsk Affiliate of Stavropol Regional Clinical Oncology Center
Pyatigorsk, , Russia
St. Petersburg City Multifield Hospital #2
Saint Petersburg, , Russia
St. Petersburg Pavlov State Medical University
Saint Petersburg, , Russia
Pavlov St. Petersburg State Medical University, Pulmonology Research Institute
Saint Petersburg, , Russia
City Clinical Oncology Center, Thoracic Oncology Department #6
Saint Petersburg, , Russia
Ogarev Mordovian State University
Saransk, , Russia
State Higher Education Institution Saratov State Medical University under the Federal Agency for Healthcare and Social Development
Saratov, , Russia
Oncology Center
Sochi, , Russia
Tambov Regional Oncology Center
Tambov, , Russia
Tomsk Regional Oncology Center
Tomsk, , Russia
Tula Regional Oncology Center
Tula, , Russia
Ufa, Republican Oncology Center
Ufa, , Russia
Primorsky Regional Oncology Center
Vladivostok, , Russia
Volgograd Regional Clinical Oncology Center#1
Volograd, , Russia
Voronezh Regional Clinical Oncology Center
Voronezh, , Russia
Regional Clinical Oncology Hospital
Yaroslavl, , Russia
Sverdlovsk Regional Oncology Center
Yekaterinburg, , Russia
Republican of Clinical Hospital, Mariy-El Republican
Yoshkar-Ola, , Russia
Clinic for Pulmonary Diseases and TBC
Knez-Selo, , Serbia
Institute for Pulmonary Diseases of Vijvodina
Vijvodina, , Serbia
Volyn Regional Oncology Center
Lutsk, , Ukraine
Public Treatment and Prevention Institution Mariupol City Interdistrict Oncology Center
Mariupol, , Ukraine
Sumy Regional Oncology Center
Sumy, , Ukraine
Ternopol Regional Clinical Oncology Center
Ternopil, , Ukraine
Zaporozhye Regional Clinical Oncology Center
Zaporizhzhya, , Ukraine
Countries
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References
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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.
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.
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.
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.
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.
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.
Related Links
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Poniard Pharmaceuticals, Inc.
Other Identifiers
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0601
Identifier Type: -
Identifier Source: org_study_id
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