Study of Picoplatin Efficacy After Relapse
This trial is active, not recruiting.
|Condition||small cell lung cancer|
|Treatments||picoplatin, best supportive care|
|Start date||April 2007|
|End date||May 2009|
|Trial size||399 participants|
|Trial identifier||NCT00465491, 0601|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Buenos Aires, Argentina||Centro Oncologico||no longer recruiting|
|Buenos Aires, Argentina||PALIAR||no longer recruiting|
|Buenos Aires, Argentina||Clinica Constituyentes||no longer recruiting|
|Buenos Aires, Argentina||CETEN Centro de Estudio y Tratamiento de Enfermedades Neoplasicas||no longer recruiting|
|Buenos Aires, Argentina||Consultorios Privados||no longer recruiting|
|Buenos Aires, Argentina||Instituto Alexander Fleming||no longer recruiting|
|Buenos Aires, Argentina||IADT (Insttituto Argentino de Diagnostico y Tratamiento S.A.)||no longer recruiting|
|Cordoba, Argentina||IONC||no longer recruiting|
|Santa Fe, Argentina||ISIS Clinica Especializada||no longer recruiting|
|Santa Fe, Argentina||Centro Oncologico de Rosario||no longer recruiting|
|Tucuman, Argentina||Centro Medico San Roque||no longer recruiting|
|Gomel, Belarus||Gomel Regional Oncological Dispensary||no longer recruiting|
|Grodno, Belarus||Institution of Healthcare "Grodno Regional Clinical Hospital||no longer recruiting|
|Minsk, Belarus||Minsk City Clinical Oncology Dispensary||no longer recruiting|
|Minsk, Belarus||Research Institute of Oncology and Medical Radiology named by N.N. Aleksandrov||no longer recruiting|
|Vitebsk, Belarus||Vitebsk Regional Oncology Dispensary||no longer recruiting|
|Banja Luka, Bosnia and Herzegovina||Clinic for Lung Diseases, Clinical Center, Banja Luka||no longer recruiting|
|Sarajevo, Bosnia and Herzegovina||Clinic of Pulmonary Diseases Podhrastovi||no longer recruiting|
|Gabrovo, Bulgaria||Multiprofile Hospital for Active Treatment, Dr. Tota Venkova||no longer recruiting|
|Pleven, Bulgaria||University Multifunctional Hospital for Active Treatment "Dr. Georgi Stranski"||no longer recruiting|
|Plovdiv, Bulgaria||District Dispensary for Cancer Diseases with Inpatient Hospital Plovdiv||no longer recruiting|
|Rousse, Bulgaria||Regional Oncodispensary with Inpatient Sector||no longer recruiting|
|Shumen, Bulgaria||Inter-district Dispensary for Cancer Diseases w/Inpatient Hospital||no longer recruiting|
|Sofia, Bulgaria||Regional Oncodispensary with Inpatient Sector-Sofia District||no longer recruiting|
|Varna, Bulgaria||Multiprofile Hospital for Active Treatment "St. Marina"||no longer recruiting|
|Varna, Bulgaria||Inter-district Dispensary for Cancer Disease w/Inpatient Hospital "Dr. Marko Markov", Varna||no longer recruiting|
|Santiago, Chile||Instituto Nacional de Cancer||no longer recruiting|
|Dubrovnik, Croatia||Clinical Hospital||no longer recruiting|
|Osijek, Croatia||Clinical Hospital||no longer recruiting|
|Split, Croatia||Clinical Hospital Split||no longer recruiting|
|Zagreb, Croatia||Clinic for Pulmonary Diseses "Jordanovac"||no longer recruiting|
|Fejer County, Hungary||St. George County Hospital||no longer recruiting|
|Szeged, Hungary||University of Szeged||no longer recruiting|
|Szombathely, Hungary||General Rehablitation and Medicinal Bath Hospital||no longer recruiting|
|Asarwa, India||Gujrat Cancer Research Institute||no longer recruiting|
|Bangalore, India||Kidwai Memorial Institute of Oncology||no longer recruiting|
|Kochin, India||Lakeshore Hospital and Research Center||no longer recruiting|
|Nasik, India||Shatabdi Superspeciality Hospital||no longer recruiting|
|Bangalore, India||Curie Centre of Oncology||no longer recruiting|
|Bhopal, India||Jawaharlal Nehru Cancer Hospital and Research Centre||no longer recruiting|
|Chennai, India||Apollo Speciality Hospital||no longer recruiting|
|Hyderabaad, India||Indo American Institute of Oncology||no longer recruiting|
|Hyderabaad, India||MNJ Institute of Oncology||no longer recruiting|
|Hyderabad, India||Yashoda Group of Hospitals||no longer recruiting|
|Jaipur, India||SEAROC Cancer Center||no longer recruiting|
|Kolkata, India||Orchid Nursing Home||no longer recruiting|
|Kolkata, India||Institute of Post Graduate Medical Education and Research||no longer recruiting|
|Lucknow, India||King George Medical University||no longer recruiting|
|Manipal, India||KMC (Karturba Medical College) Hospital||no longer recruiting|
|Mumbai, India||Tata Memorial Centre||no longer recruiting|
|Mumbai, India||Jaslok Hospital and Research Centre||no longer recruiting|
|New Delhi, India||Sir Ganga Ram Hospital||no longer recruiting|
|New Delhi, India||Rajiv Gandhi Cancer Institute, Delhi||no longer recruiting|
|Patna, India||Mahaveer Cancer Sansthan||no longer recruiting|
|Pune, India||Jahangir Hospital and Research Centre||no longer recruiting|
|Rajkot, India||Smt. Vasantben R. Desai Cancer Research Center||no longer recruiting|
|Trivandrum, India||Regional Cancer Centre||no longer recruiting|
|Vishakhapatnam, India||King George Hospital||no longer recruiting|
|Daugavpils, Latvia||Daugavas Hospital||no longer recruiting|
|Riga, Latvia||Paul Stradins Clincial University Hospital||no longer recruiting|
|Niksic, Montenegro||Special Hospital for Pulmonary Diseases||no longer recruiting|
|Wroclaw, Poland||Dolnoslaskie Centre of Lung Diseases||no longer recruiting|
|Zabrze, Poland||Silesian Medical University in Katowice||no longer recruiting|
|Bydgoszcz, Poland||Kujawsko-Pomorski Centre of Pulmonology||no longer recruiting|
|Czestochowa, Poland||NMP, Memorial Voyvodship Hospital||no longer recruiting|
|Grudziadz, Poland||Dr. Bieganski Memorial Regional Specialsitic Hospital||no longer recruiting|
|Krakow, Poland||Regional Hospital, Department of Pulmonary Diseases and Chemotherapy||no longer recruiting|
|Olsztyn, Poland||Independent Public Group for Tuberculosis and Lung Disease in Olsztyn||no longer recruiting|
|Plock, Poland||Conservative Outpatient Oncology Department, Voyevodship Hospital in Plock||no longer recruiting|
|Poznan, Poland||Department of Clinical Oncology, Wielkopolskie Centre of Lung Diseases and Tuberculosis||no longer recruiting|
|Radom, Poland||Department of Pulmonology, Voyvodship Specialsitic Hospital in Radom||no longer recruiting|
|Rybnik, Poland||SP ZOZ Voyevodship Specialistic Hospital #3||no longer recruiting|
|Szczecin, Poland||Department of Chemotherapy, Prof. A. Sokolowski Memorial Specialistic Hospital in Szczecin||no longer recruiting|
|Torun, Poland||Department of Clinical Oncology, SP ZOZ, Yoyvodship Specialistic Hospital||no longer recruiting|
|Cluj-Napoca, Romania||Prof. Dr. Ion Chiricuta, Institute of Oncology Cluj-Napoca||no longer recruiting|
|Baia Mare, Romania||Baia Mare "Constantin Opris" County Emergency Hospital||no longer recruiting|
|Bucharest, Romania||IANULI Medconsult SRL||no longer recruiting|
|Bucharest, Romania||Bucharest Institute of Oncology||no longer recruiting|
|Cluj-Napoca, Romania||Prof. Dr. Ion Chircuta, Oncology Institute||no longer recruiting|
|Constanta, Romania||Clinical Emergency County Hospital Constanta||no longer recruiting|
|Iasi, Romania||Medical Oncology Center Iasi||no longer recruiting|
|Ploiesti, Romania||Schuller Municipal Hospital Ploiesti-Medical Oncology Department||no longer recruiting|
|Sibiu, Romania||Clinical County Hospital||no longer recruiting|
|Suceava, Romania||Sf. loan cel Nou, Emergency County Hospital||no longer recruiting|
|Timisoara, Romania||OncoMed||no longer recruiting|
|Ulan-Ude, Russian Federation||Buryatia Republican Oncology Center||no longer recruiting|
|Birobidzhan, Russian Federation||Regional Oncology Center||no longer recruiting|
|Petrozavodsk, Russian Federation||Republican Oncology Center of the Ministry of Healthcare of Karelia Republic||no longer recruiting|
|Syktyvkar, Russian Federation||Komi Republican Oncology Center||no longer recruiting|
|Kazan, Russian Federation||Clinical Oncology Center||no longer recruiting|
|Kazan, Russian Federation||Kazan Oncology Center||no longer recruiting|
|Arkhangelsk, Russian Federation||Arkhangelsk Regional Clinical Oncology Center||no longer recruiting|
|Barnaul, Russian Federation||Altai Regional Oncology Center||no longer recruiting|
|Chelyabinsk, Russian Federation||Chelyabinsk Regional Oncology Center||no longer recruiting|
|Cherepovets, Russian Federation||City Hospital #1||no longer recruiting|
|Chita, Russian Federation||Chita Regional Oncology Center||no longer recruiting|
|Ekaterinburg, Russian Federation||Sverdlovsk Regional Oncology Center||no longer recruiting|
|Engels, Russian Federation||Regional Oncology Center||no longer recruiting|
|Irkutsk, Russian Federation||Regional Oncology Center||no longer recruiting|
|Ivanovo, Russian Federation||Ivanovo Regional Oncology Center||no longer recruiting|
|Izhevsk, Russian Federation||Republican Clinical Oncology Center of the Republic of Udmurtia||no longer recruiting|
|Kaluga, Russian Federation||Kaluga Regional Oncology Center||no longer recruiting|
|Khabarovsk, Russian Federation||Regional Clinical Oncology Center||no longer recruiting|
|Kirov, Russian Federation||Regional Clinical Oncology Center||no longer recruiting|
|Komsomolsk-na-Amure, Russian Federation||City Oncology Center||no longer recruiting|
|Krasnodar, Russian Federation||Krasnodar Clinical Oncology||no longer recruiting|
|Krasnodar, Russian Federation||Regional Clinical Hospital #1||no longer recruiting|
|Kurst, Russian Federation||Kurst Regional Oncology Center||no longer recruiting|
|Lipetsk, Russian Federation||Lipetsk Regional Oncology Center||no longer recruiting|
|Magnitogorsk, Russian Federation||Magnitogorsk Clinical Oncology Hospital||no longer recruiting|
|Moscow, Russian Federation||Central Clinical Hospital and Outpatient Unit of the Medical Center under the Russian Presidential Administration||no longer recruiting|
|Moscow, Russian Federation||Semashko Central Clinical Hospital #2 under Russian Railways||no longer recruiting|
|Moscow, Russian Federation||Blokhin Russian Oncology Research Center||no longer recruiting|
|Novorossiysk, Russian Federation||Novorossiysk Oncology Center||no longer recruiting|
|Novosibirsk, Russian Federation||City Clinical Hospital #1||no longer recruiting|
|Obnninsk, Russian Federation||Medical Radiology Research Center under RAMS||no longer recruiting|
|Orel, Russian Federation||Orel Oncology Center||no longer recruiting|
|Orenburg, Russian Federation||Orenburg Regional Clinical Oncology Center||no longer recruiting|
|Penza, Russian Federation||Regional Oncology Center||no longer recruiting|
|Pyatigorsk, Russian Federation||Pyatigorsk Affiliate of Stavropol Regional Clinical Oncology Center||no longer recruiting|
|Saransk, Russian Federation||Ogarev Mordovian State University||no longer recruiting|
|Saratov, Russian Federation||State Higher Education Institution Saratov State Medical University under the Federal Agency for Healthcare and Social Development||no longer recruiting|
|Sochi, Russian Federation||Oncology Center||no longer recruiting|
|St. Petersburg, Russian Federation||Pavlov St. Petersburg State Medical University, Pulmonology Research Institute||no longer recruiting|
|St. Petersburg, Russian Federation||St. Petersburg City Multifield Hospital #2||no longer recruiting|
|St. Petersburg, Russian Federation||City Clinical Oncology Center, Thoracic Oncology Department #6||no longer recruiting|
|St. Petersburg, Russian Federation||St. Petersburg Pavlov State Medical University||no longer recruiting|
|Tambov, Russian Federation||Tambov Regional Oncology Center||no longer recruiting|
|Tomsk, Russian Federation||Tomsk Regional Oncology Center||no longer recruiting|
|Tula, Russian Federation||Tula Regional Oncology Center||no longer recruiting|
|Ufa, Russian Federation||Ufa, Republican Oncology Center||no longer recruiting|
|Vladivostok, Russian Federation||Primorsky Regional Oncology Center||no longer recruiting|
|Volograd, Russian Federation||Volgograd Regional Clinical Oncology Center#1||no longer recruiting|
|Voronezh, Russian Federation||Voronezh Regional Clinical Oncology Center||no longer recruiting|
|Yaroslavl, Russian Federation||Regional Clinical Oncology Hospital||no longer recruiting|
|Yoshkar-Ola, Russian Federation||Republican of Clinical Hospital, Mariy-El Republican||no longer recruiting|
|Knez Selo, Serbia||Clinic for Pulmonary Diseases and TBC||no longer recruiting|
|Vijvodina, Serbia||Institute for Pulmonary Diseases of Vijvodina||no longer recruiting|
|Lutsk, Ukraine||Volyn Regional Oncology Center||no longer recruiting|
|Mariupol, Ukraine||Public Treatment and Prevention Institution Mariupol City Interdistrict Oncology Center||no longer recruiting|
|Sumy, Ukraine||Sumy Regional Oncology Center||no longer recruiting|
|Ternopol, Ukraine||Ternopol Regional Clinical Oncology Center||no longer recruiting|
|Zaporozhye, Ukraine||Zaporozhye Regional Clinical Oncology Center||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
time frame: death
objective response rate
time frame: progression
disease control rate
time frame: progression
duration of response
time frame: progression
time frame: death
Male or female participants at least 18 years old.
- 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).
- 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.
- 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.
- History of any other malignancy within 5 years, with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix.
|Official title||A Randomized, Controlled Phase III Trial of Picoplatin and BSC Versus BSC Alone in Patients With Small Cell Lung Cancer (SCLC), Refractory or Progressive Within Six Months of Completing First-Line, Platinum-Containing Chemotherapy.|
|Description||This Phase 3 study will enroll subjects with Small Cell Lung Cancer (SCLC) who are refractory or progressive within 6 months of completing first-line, platinum-containing chemotherapy. Subjects will be centrally randomized 2:1 to receive picoplatin plus BSC every 3 weeks, or BSC alone. After discontinuation of picoplatin, all subjects will continue to receive BSC and will continue to be evaluated every 3 weeks until discontinuation from the study, death, or the end of the study. After discontinuation of picoplatin, subjects may be treated with another chemotherapy at their physician's discretion and then will be followed for survival.|
Call for more information