Study of Picoplatin Efficacy After Relapse (SPEAR)

April 13, 2009 updated by: Poniard Pharmaceuticals

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

399

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B1704ESN
        • Consultorios Privados
      • Buenos Aires, Argentina, B1708KCH
        • Clínica Constituyentes
      • Buenos Aires, Argentina, B1874ACL
        • CETEN Centro de Estudio y Tratamiento de Enfermedades Neoplasicas
      • Buenos Aires, Argentina, C1122AAL
        • IADT (Insttituto Argentino de Diagnostico y Tratamiento S.A.)
      • Buenos Aires, Argentina, C1212ACA
        • Centro Oncologico
      • Buenos Aires, Argentina, C1426ANZ
        • Instituto Alexander Fleming
      • Buenos Aires, Argentina, C1430ERF
        • Paliar
      • Cordoba, Argentina, X5000AAI
        • IONC
      • Santa Fe, Argentina, S2000DSK
        • Centro Oncologico de Rosario
      • Santa Fe, Argentina, S3002EKI
        • ISIS Clinica Especializada
      • Tucuman, Argentina, T4000IAA
        • Centro Medico San Roque
  • Belarus
      • Gomel, Belarus, 246012
        • Gomel Regional Oncological Dispensary
      • Grodno, Belarus, 230017
        • Institution of Healthcare "Grodno Regional Clinical Hospital
      • Minsk, Belarus, 220013
        • Minsk City Clinical Oncology Dispensary
      • Minsk, Belarus, 223040
        • Research Institute of Oncology and Medical Radiology named by N.N. Aleksandrov
      • Vitebsk, Belarus, 210603
        • Vitebsk Regional Oncology Dispensary
  • Bosnia and Herzegovina
      • Banja Luka, Bosnia and Herzegovina, 78000
        • Clinic for Lung Diseases, Clinical Center, Banja Luka
      • Sarajevo, Bosnia and Herzegovina
        • Clinic of Pulmonary Diseases Podhrastovi
  • Bulgaria
      • Gabrovo, Bulgaria, 5300
        • Multiprofile Hospital for Active Treatment, Dr. Tota Venkova
      • Pleven, Bulgaria, 5800
        • University Multifunctional Hospital for Active Treatment "Dr. Georgi Stranski"
      • Plovdiv, Bulgaria, 4004
        • District Dispensary for Cancer Diseases with Inpatient Hospital Plovdiv
      • Rousse, Bulgaria, 7000
        • Regional Oncodispensary with Inpatient Sector
      • Shumen, Bulgaria, 9700
        • Inter-district Dispensary for Cancer Diseases w/Inpatient Hospital
      • Sofia, Bulgaria, 1233
        • Regional Oncodispensary with inpatient sector-Sofia District
      • Varna, Bulgaria, 9010
        • Inter-district Dispensary for Cancer Disease w/Inpatient Hospital "Dr. Marko Markov", Varna
      • Varna, Bulgaria, 9010
        • Multiprofile Hospital for Active Treatment "St. Marina"
  • Chile
      • Santiago, Chile, 2363058
        • Instituto Nacional de Cancer
  • Croatia
      • Dubrovnik, Croatia
        • Clinical Hospital
      • Osijek, Croatia, 31000
        • Clinical Hospital
      • Split, Croatia, 2001
        • Clinical Hospital Split
      • Zagreb, Croatia
        • Clinic for Pulmonary Diseses "Jordanovac"
  • Hungary
      • Fejer County, Hungary, 8000
        • St. George County Hospital
      • Szeged, Hungary, 6772
        • University of Szeged
      • Szombathely, Hungary, 9700
        • General Rehablitation and Medicinal Bath Hospital
  • India
      • Bangalore, India, 560034
        • Curie Centre of Oncology
      • Bhopal, India
        • Jawaharlal Nehru Cancer Hospital and Research Centre
      • Chennai, India, 600035
        • Apollo Speciality Hospital
      • Hyderabaad, India, 500004
        • MNJ Institute of Oncology
      • Hyderabaad, India, 500034
        • Indo American Institute of Oncology
      • Hyderabad, India, 500082
        • Yashoda Group of Hospitals
      • Jaipur, India, 302013
        • Searoc Cancer Center
      • Kolkata, India, 700020
        • Institute of Post Graduate Medical Education And Research
      • Kolkata, India, 700054
        • Orchid Nursing Home
      • Lucknow, India
        • King George Medical University
      • Manipal, India
        • KMC (Karturba Medical College) Hospital
      • Mumbai, India, 400026
        • Jaslok Hospital and Research Centre
      • Mumbai, India
        • Tata Memorial Centre
      • New Delhi, India, 110060
        • Sir Ganga Ram Hospital
      • New Delhi, India, 110085
        • Rajiv Gandhi Cancer Institute, Delhi
      • Patna, India, 801505
        • Mahaveer Cancer Sansthan
      • Pune, India, 411001
        • Jahangir Hospital and Research Centre
      • Rajkot, India, 360007
        • Smt. Vasantben R. Desai Cancer Research Center
      • Trivandrum, India, 695011
        • Regional Cancer Centre
      • Vishakhapatnam, India
        • King George Hospital
    • Ahmadabad
      • Asarwa, Ahmadabad, India, 380016
        • Gujrat Cancer Research Institute
    • Karnataka
      • Bangalore, Karnataka, India, 560029
        • Kidwai Memorial Institute of Oncology
    • Kerala
      • Kochin, Kerala, India, 682304
        • Lakeshore Hospital and Research Center
    • Maharashtra
      • Nasik, Maharashtra, India, 422005
        • Shatabdi Superspeciality Hospital
  • Latvia
      • Daugavpils, Latvia, 5420
        • Daugavas Hospital
      • Riga, Latvia, 1002
        • Paul Stradins Clincial University Hospital
  • Montenegro
      • Niksic, Montenegro, 81400
        • Special Hospital for Pulmonary Diseases
  • Poland
      • Bydgoszcz, Poland, 85-326
        • Kujawsko-Pomorski Centre of Pulmonology
      • Czestochowa, Poland, 42200
        • NMP, Memorial Voyvodship Hospital
      • Grudziadz, Poland, 86-300
        • Dr. Bieganski Memorial Regional Specialsitic Hospital
      • Krakow, Poland, 31202
        • Regional Hospital, Department of Pulmonary Diseases and Chemotherapy
      • Olsztyn, Poland, 10-357
        • Independent Public Group for Tuberculosis and Lung Disease in Olsztyn
      • Plock, Poland, 09-400
        • Conservative Outpatient Oncology Department, Voyevodship Hospital in Plock
      • Poznan, Poland, 60-569
        • Department of Clinical Oncology, Wielkopolskie Centre of Lung Diseases and Tuberculosis
      • Radom, Poland, 26-617
        • Department of Pulmonology, Voyvodship Specialsitic Hospital in Radom
      • Rybnik, Poland, 44-200
        • SP ZOZ Voyevodship Specialistic Hospital #3
      • Szczecin, Poland, 70-891
        • Department of Chemotherapy, Prof. A. Sokolowski Memorial Specialistic Hospital in Szczecin
      • Torun, Poland, 87-100
        • Department of Clinical Oncology, SP ZOZ, Yoyvodship Specialistic Hospital
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 53-439
        • Dolnoslaskie Centre of Lung Diseases
    • Dolny Slask
      • Zabrze, Dolny Slask, Poland, 41-803
        • Silesian Medical University in Katowice
  • Romania
      • Bucharest, Romania, 020962
        • IANULI Medconsult SRL
      • Bucharest, Romania, 022328
        • Bucharest Institute of Oncology
      • Cluj-Napoca, Romania, 400015
        • Prof. Dr. Ion Chircuta, Oncology Institute
      • Constanta, Romania, 900591
        • Clinical Emergency County Hospital Constanta
      • Iasi, Romania, 700106
        • Medical Oncology Center Iasi
      • Ploiesti, Romania, 100337
        • Schuller Municipal Hospital Ploiesti-Medical Oncology Department
      • Sibiu, Romania, 550245
        • Clinical county Hospital
      • Suceava, Romania
        • Sf. loan cel Nou, Emergency County Hospital
      • Timisoara, Romania, 300239
        • Oncomed
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Prof. Dr. Ion Chiricuta, Institute of Oncology Cluj-Napoca
    • Maramures County
      • Baia Mare, Maramures County, Romania, 4800
        • Baia Mare "Constantin Opris" County Emergency Hospital
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • Arkhangelsk Regional Clinical Oncology Center
      • Barnaul, Russian Federation, 656049
        • Altai Regional Oncology Center
      • Chelyabinsk, Russian Federation, 454087
        • Chelyabinsk Regional Oncology Center
      • Cherepovets, Russian Federation, 162627
        • City Hospital #1
      • Chita, Russian Federation, 672027
        • Chita Regional Oncology Center
      • Ekaterinburg, Russian Federation, 620036
        • Sverdlovsk Regional Oncology Center
      • Engels, Russian Federation, 413115
        • Regional Oncology Center
      • Irkutsk, Russian Federation, 664035
        • Regional Oncology Center
      • Ivanovo, Russian Federation, 214000
        • Ivanovo Regional Oncology Center
      • Izhevsk, Russian Federation, 426009
        • Republican Clinical Oncology Center of the Republic of Udmurtia
      • Kaluga, Russian Federation, 248007
        • Kaluga Regional Oncology Center
      • Khabarovsk, Russian Federation, 680042
        • Regional Clinical Oncology Center
      • Kirov, Russian Federation, 610021
        • Regional Clinical Oncology Center
      • Komsomolsk-na-Amure, Russian Federation, 681000
        • City Oncology Center
      • Krasnodar, Russian Federation, 350040
        • Krasnodar Clinical Oncology
      • Krasnodar, Russian Federation, 350086
        • Regional Clinical Hospital #1
      • Kurst, Russian Federation
        • Kurst Regional Oncology Center
      • Lipetsk, Russian Federation, 398005
        • Lipetsk Regional Oncology Center
      • Magnitogorsk, Russian Federation, 455001
        • Magnitogorsk Clinical Oncology Hospital
      • Moscow, Russian Federation, 115478
        • Blokhin Russian Oncology Research Center
      • Moscow, Russian Federation, 121359
        • Central Clinical Hospital and Outpatient Unit of the Medical Center under the Russian Presidential Administration
      • Moscow, Russian Federation, 129128
        • Semashko Central Clinical Hospital #2 under Russian Railways
      • Novorossiysk, Russian Federation, 353915
        • Novorossiysk Oncology Center
      • Novosibirsk, Russian Federation, 630047
        • City Clinical Hospital #1
      • Obnninsk, Russian Federation, 249036
        • Medical Radiology Research Center under RAMS
      • Orel, Russian Federation, 302020
        • Orel Oncology Center
      • Orenburg, Russian Federation, 460021
        • Orenburg Regional Clinical Oncology Center
      • Penza, Russian Federation, 440071
        • Regional Oncology Center
      • Pyatigorsk, Russian Federation, 357502
        • Pyatigorsk Affiliate of Stavropol Regional Clinical Oncology Center
      • Saransk, Russian Federation, 430032
        • Ogarev Mordovian State University
      • Saratov, Russian Federation, 410012
        • State Higher Education Institution Saratov State Medical University under the Federal Agency for Healthcare and Social Development
      • Sochi, Russian Federation, 354057
        • Oncology Center
      • St. Petersburg, Russian Federation, 197022
        • St. Petersburg Pavlov State Medical University
      • St. Petersburg, Russian Federation, 194354
        • St. Petersburg City Multifield Hospital #2
      • St. Petersburg, Russian Federation, 197101
        • Pavlov St. Petersburg State Medical University, Pulmonology Research Institute
      • St. Petersburg, Russian Federation, 198255
        • City Clinical Oncology Center, Thoracic Oncology Department #6
      • Tambov, Russian Federation, 390013
        • Tambov Regional Oncology Center
      • Tomsk, Russian Federation, 634050
        • Tomsk Regional Oncology Center
      • Tula, Russian Federation, 300040
        • Tula Regional Oncology Center
      • Ufa, Russian Federation
        • Ufa, Republican Oncology Center
      • Vladivostok, Russian Federation, 690105
        • Primorsky Regional Oncology Center
      • Volograd, Russian Federation, 400138
        • Volgograd Regional Clinical Oncology Center#1
      • Voronezh, Russian Federation, 394000
        • Voronezh Regional Clinical Oncology Center
      • Yaroslavl, Russian Federation, 150054
        • Regional Clinical Oncology Hospital
      • Yoshkar-Ola, Russian Federation, 424037
        • Republican of Clinical Hospital, Mariy-El Republican
    • Buryatia
      • Ulan-Ude, Buryatia, Russian Federation, 670047
        • Buryatia Republican Oncology Center
    • Jewish Republic
      • Birobidzhan, Jewish Republic, Russian Federation, 679016
        • Regional Oncology Center
    • Karelia Republic
      • Petrozavodsk, Karelia Republic, Russian Federation, 185007
        • Republican Oncology Center of the Ministry of Healthcare of Karelia Republic
    • Komi Republic
      • Syktyvkar, Komi Republic, Russian Federation, 167904
        • Komi Republican Oncology Center
    • Tatarstan Republic
      • Kazan, Tatarstan Republic, Russian Federation, 420029
        • Clinical Oncology Center
      • Kazan, Tatarstan Republic, Russian Federation, 420111
        • Kazan Oncology Center
  • Serbia
      • Knez Selo, Serbia
        • Clinic for Pulmonary Diseases and TBC
      • Vijvodina, Serbia
        • Institute for Pulmonary Diseases of Vijvodina
  • Ukraine
      • Lutsk, Ukraine, 43018
        • Volyn Regional Oncology Center
      • Mariupol, Ukraine, 87500
        • Public Treatment and Prevention Institution Mariupol City Interdistrict Oncology Center
      • Sumy, Ukraine, 40005
        • Sumy Regional Oncology Center
      • Ternopol, Ukraine, 46023
        • Ternopol Regional Clinical Oncology Center
      • Zaporozhye, Ukraine, 69040
        • Zaporozhye Regional Clinical Oncology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Picoplatin
Drug: picoplatin
IV picoplatin 150mg/m2 q3wk
Other: 2
BSC
Other: best supportive care
best supportive care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: death
death

Secondary Outcome Measures

Outcome Measure
Time Frame
objective response rate
Time Frame: progression
progression
disease control rate
Time Frame: progression
progression
duration of response
Time Frame: progression
progression
progression-free survival
Time Frame: death
death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poniard Pharmaceuticals

Investigators

  • Study Director: Dr. Hazel Breitz, M.D., Poniard Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Anticipated)

May 1, 2009

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

April 23, 2007

First Submitted That Met QC Criteria

April 23, 2007

First Posted (Estimate)

April 25, 2007

Study Record Updates

Last Update Posted (Estimate)

April 14, 2009

Last Update Submitted That Met QC Criteria

April 13, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0601

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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