Study of Picoplatin Efficacy After Relapse
- Registration Number
- NCT00465491
- Lead Sponsor
- Poniard Pharmaceuticals
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 399
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 picoplatin Picoplatin 2 best supportive care BSC
- Primary Outcome Measures
Name Time Method overall survival death
- Secondary Outcome Measures
Name Time Method duration of response progression progression-free survival death objective response rate progression disease control rate progression
Trial Locations
- Locations (138)
Gujrat Cancer Research Institute
🇮🇳Asarwa, Ahmadabad, India
Centro Oncologico
🇦🇷Buenos Aires, Argentina
Instituto Alexander Fleming
🇦🇷Buenos Aires, Argentina
Gomel Regional Oncological Dispensary
🇧🇾Gomel, Belarus
Vitebsk Regional Oncology Dispensary
🇧🇾Vitebsk, Belarus
Regional Oncodispensary with Inpatient Sector
🇧🇬Rousse, Bulgaria
Special Hospital for Pulmonary Diseases
🇲🇪Niksic, Montenegro
Clinical Hospital Split
🇭🇷Split, Croatia
General Rehablitation and Medicinal Bath Hospital
🇭🇺Szombathely, Hungary
Mahaveer Cancer Sansthan
🇮🇳Patna, India
Jahangir Hospital and Research Centre
🇮🇳Pune, India
Paul Stradins Clincial University Hospital
🇱🇻Riga, Latvia
Smt. Vasantben R. Desai Cancer Research Center
🇮🇳Rajkot, India
Regional Cancer Centre
🇮🇳Trivandrum, India
IANULI Medconsult SRL
🇷🇴Bucharest, Romania
Komi Republican Oncology Center
🇷🇺Syktyvkar, Komi Republic, Russian Federation
Chita Regional Oncology Center
🇷🇺Chita, Russian Federation
Magnitogorsk Clinical Oncology Hospital
🇷🇺Magnitogorsk, Russian Federation
Central Clinical Hospital and Outpatient Unit of the Medical Center under the Russian Presidential Administration
🇷🇺Moscow, Russian Federation
City Oncology Center
🇷🇺Komsomolsk-na-Amure, Russian Federation
Regional Clinical Hospital #1
🇷🇺Krasnodar, Russian Federation
Novorossiysk Oncology Center
🇷🇺Novorossiysk, Russian Federation
Semashko Central Clinical Hospital #2 under Russian Railways
🇷🇺Moscow, Russian Federation
City Clinical Hospital #1
🇷🇺Novosibirsk, Russian Federation
Medical Radiology Research Center under RAMS
🇷🇺Obnninsk, Russian Federation
Tula Regional Oncology Center
🇷🇺Tula, Russian Federation
Ufa, Republican Oncology Center
🇷🇺Ufa, Russian Federation
Volgograd Regional Clinical Oncology Center#1
🇷🇺Volograd, Russian Federation
Clinic for Pulmonary Diseases and TBC
🇷🇸Knez Selo, Serbia
Institute for Pulmonary Diseases of Vijvodina
🇷🇸Vijvodina, Serbia
Volyn Regional Oncology Center
🇺🇦Lutsk, Ukraine
Sumy Regional Oncology Center
🇺🇦Sumy, Ukraine
Ternopol Regional Clinical Oncology Center
🇺🇦Ternopol, Ukraine
Zaporozhye Regional Clinical Oncology Center
🇺🇦Zaporozhye, Ukraine
CETEN Centro de Estudio y Tratamiento de Enfermedades Neoplasicas
🇦🇷Buenos Aires, Argentina
IADT (Insttituto Argentino de Diagnostico y Tratamiento S.A.)
🇦🇷Buenos Aires, Argentina
Consultorios Privados
🇦🇷Buenos Aires, Argentina
Clinica Constituyentes
🇦🇷Buenos Aires, Argentina
Centro Oncologico de Rosario
🇦🇷Santa Fe, Argentina
PALIAR
🇦🇷Buenos Aires, Argentina
Centro Medico San Roque
🇦🇷Tucuman, Argentina
Minsk City Clinical Oncology Dispensary
🇧🇾Minsk, Belarus
IONC
🇦🇷Cordoba, Argentina
Research Institute of Oncology and Medical Radiology named by N.N. Aleksandrov
🇧🇾Minsk, Belarus
Clinic for Lung Diseases, Clinical Center, Banja Luka
🇧🇦Banja Luka, Bosnia and Herzegovina
University Multifunctional Hospital for Active Treatment "Dr. Georgi Stranski"
🇧🇬Pleven, Bulgaria
Clinic of Pulmonary Diseases Podhrastovi
🇧🇦Sarajevo, Bosnia and Herzegovina
Multiprofile Hospital for Active Treatment, Dr. Tota Venkova
🇧🇬Gabrovo, Bulgaria
Regional Oncodispensary with Inpatient Sector-Sofia District
🇧🇬Sofia, Bulgaria
Instituto Nacional de Cancer
🇨🇱Santiago, Chile
St. George County Hospital
🇭🇺Fejer County, Hungary
Clinical Hospital
🇭🇷Osijek, Croatia
Apollo Speciality Hospital
🇮🇳Chennai, India
Yashoda Group of Hospitals
🇮🇳Hyderabad, India
Orchid Nursing Home
🇮🇳Kolkata, India
Sir Ganga Ram Hospital
🇮🇳New Delhi, India
Jawaharlal Nehru Cancer Hospital and Research Centre
🇮🇳Bhopal, India
Indo American Institute of Oncology
🇮🇳Hyderabaad, India
SEAROC Cancer Center
🇮🇳Jaipur, India
MNJ Institute of Oncology
🇮🇳Hyderabaad, India
King George Medical University
🇮🇳Lucknow, India
KMC (Karturba Medical College) Hospital
🇮🇳Manipal, India
Rajiv Gandhi Cancer Institute, Delhi
🇮🇳New Delhi, India
King George Hospital
🇮🇳Vishakhapatnam, India
Daugavas Hospital
🇱🇻Daugavpils, Latvia
Dolnoslaskie Centre of Lung Diseases
🇵🇱Wroclaw, Dolnoslaskie, Poland
NMP, Memorial Voyvodship Hospital
🇵🇱Czestochowa, Poland
Kujawsko-Pomorski Centre of Pulmonology
🇵🇱Bydgoszcz, 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
🇵🇱Plock, Poland
Medical Oncology Center Iasi
🇷🇴Iasi, Romania
SP ZOZ Voyevodship Specialistic Hospital #3
🇵🇱Rybnik, Poland
Department of Chemotherapy, Prof. A. Sokolowski Memorial Specialistic Hospital in Szczecin
🇵🇱Szczecin, Poland
Sf. loan cel Nou, Emergency County Hospital
🇷🇴Suceava, Romania
OncoMed
🇷🇴Timisoara, Romania
Regional Oncology Center
🇷🇺Penza, Russian Federation
Chelyabinsk Regional Oncology Center
🇷🇺Chelyabinsk, Russian Federation
Clinical County Hospital
🇷🇴Sibiu, Romania
Buryatia Republican Oncology Center
🇷🇺Ulan-Ude, Buryatia, Russian Federation
Republican Oncology Center of the Ministry of Healthcare of Karelia Republic
🇷🇺Petrozavodsk, Karelia Republic, Russian Federation
Clinical Oncology Center
🇷🇺Kazan, Tatarstan Republic, Russian Federation
City Hospital #1
🇷🇺Cherepovets, Russian Federation
Kaluga Regional Oncology Center
🇷🇺Kaluga, Russian Federation
Regional Clinical Oncology Center
🇷🇺Kirov, Russian Federation
Krasnodar Clinical Oncology
🇷🇺Krasnodar, Russian Federation
Blokhin Russian Oncology Research Center
🇷🇺Moscow, Russian Federation
Orel Oncology Center
🇷🇺Orel, Russian Federation
Orenburg Regional Clinical Oncology Center
🇷🇺Orenburg, Russian Federation
Pyatigorsk Affiliate of Stavropol Regional Clinical Oncology Center
🇷🇺Pyatigorsk, Russian Federation
Ogarev Mordovian State University
🇷🇺Saransk, Russian Federation
St. Petersburg City Multifield Hospital #2
🇷🇺St. Petersburg, Russian Federation
City Clinical Oncology Center, Thoracic Oncology Department #6
🇷🇺St. Petersburg, Russian Federation
Public Treatment and Prevention Institution Mariupol City Interdistrict Oncology Center
🇺🇦Mariupol, Ukraine
Tambov Regional Oncology Center
🇷🇺Tambov, Russian Federation
Tomsk Regional Oncology Center
🇷🇺Tomsk, Russian Federation
Voronezh Regional Clinical Oncology Center
🇷🇺Voronezh, Russian Federation
Regional Clinical Oncology Hospital
🇷🇺Yaroslavl, Russian Federation
Primorsky Regional Oncology Center
🇷🇺Vladivostok, Russian Federation
Republican of Clinical Hospital, Mariy-El Republican
🇷🇺Yoshkar-Ola, Russian Federation
Multiprofile Hospital for Active Treatment "St. Marina"
🇧🇬Varna, Bulgaria
Shatabdi Superspeciality Hospital
🇮🇳Nasik, Maharashtra, India
District Dispensary for Cancer Diseases with Inpatient Hospital Plovdiv
🇧🇬Plovdiv, Bulgaria
University of Szeged
🇭🇺Szeged, Hungary
Inter-district Dispensary for Cancer Disease w/Inpatient Hospital "Dr. Marko Markov", Varna
🇧🇬Varna, Bulgaria
Curie Centre of Oncology
🇮🇳Bangalore, India
Lakeshore Hospital and Research Center
🇮🇳Kochin, Kerala, India
Oncology Center
🇷🇺Sochi, Russian Federation
St. Petersburg Pavlov State Medical University
🇷🇺St. Petersburg, Russian Federation
Clinical Emergency County Hospital Constanta
🇷🇴Constanta, Romania
Inter-district Dispensary for Cancer Diseases w/Inpatient Hospital
🇧🇬Shumen, Bulgaria
Altai Regional Oncology Center
🇷🇺Barnaul, Russian Federation
ISIS Clinica Especializada
🇦🇷Santa Fe, Argentina
Clinic for Pulmonary Diseses "Jordanovac"
🇭🇷Zagreb, Croatia
Institute of Post Graduate Medical Education and Research
🇮🇳Kolkata, India
Jaslok Hospital and Research Centre
🇮🇳Mumbai, India
Tata Memorial Centre
🇮🇳Mumbai, India
Institution of Healthcare "Grodno Regional Clinical Hospital
🇧🇾Grodno, Belarus
Kidwai Memorial Institute of Oncology
🇮🇳Bangalore, Karnataka, India
Silesian Medical University in Katowice
🇵🇱Zabrze, Dolny Slask, Poland
Dr. Bieganski Memorial Regional Specialsitic Hospital
🇵🇱Grudziadz, Poland
Regional Hospital, Department of Pulmonary Diseases and Chemotherapy
🇵🇱Krakow, Poland
Department of Pulmonology, Voyvodship Specialsitic Hospital in Radom
🇵🇱Radom, 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, Maramures County, Romania
Bucharest Institute of Oncology
🇷🇴Bucharest, Romania
Prof. Dr. Ion Chircuta, Oncology Institute
🇷🇴Cluj-Napoca, Romania
Schuller Municipal Hospital Ploiesti-Medical Oncology Department
🇷🇴Ploiesti, Romania
Kazan Oncology Center
🇷🇺Kazan, Tatarstan Republic, Russian Federation
Arkhangelsk Regional Clinical Oncology Center
🇷🇺Arkhangelsk, Russian Federation
Sverdlovsk Regional Oncology Center
🇷🇺Ekaterinburg, Russian Federation
Ivanovo Regional Oncology Center
🇷🇺Ivanovo, Russian Federation
Republican Clinical Oncology Center of the Republic of Udmurtia
🇷🇺Izhevsk, Russian Federation
Kurst Regional Oncology Center
🇷🇺Kurst, Russian Federation
Lipetsk Regional Oncology Center
🇷🇺Lipetsk, Russian Federation
State Higher Education Institution Saratov State Medical University under the Federal Agency for Healthcare and Social Development
🇷🇺Saratov, Russian Federation
Pavlov St. Petersburg State Medical University, Pulmonology Research Institute
🇷🇺St. Petersburg, Russian Federation