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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00465491
Other study ID # 0601
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received April 23, 2007
Last updated April 13, 2009
Start date April 2007

Study information

Verified date April 2009
Source Poniard Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationEuropean Union: European Medicines AgencyRussia: Pharmacological Committee, Ministry of Health
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Active, not recruiting
Enrollment 399
Est. completion date
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
picoplatin
IV picoplatin 150mg/m2 q3wk
Other:
best supportive care
best supportive care

Locations

Country Name City State
Argentina Centro Oncologico Buenos Aires
Argentina CETEN Centro de Estudio y Tratamiento de Enfermedades Neoplasicas Buenos Aires
Argentina Clinica Constituyentes Buenos Aires
Argentina Consultorios Privados Buenos Aires
Argentina IADT (Insttituto Argentino de Diagnostico y Tratamiento S.A.) Buenos Aires
Argentina Instituto Alexander Fleming Buenos Aires
Argentina PALIAR Buenos Aires
Argentina IONC Cordoba
Argentina Centro Oncologico de Rosario Santa Fe
Argentina ISIS Clinica Especializada Santa Fe
Argentina Centro Medico San Roque Tucuman
Belarus Gomel Regional Oncological Dispensary Gomel
Belarus Institution of Healthcare "Grodno Regional Clinical Hospital Grodno
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
Bosnia and Herzegovina Clinic for Lung Diseases, Clinical Center, Banja Luka Banja Luka
Bosnia and Herzegovina Clinic of Pulmonary Diseases Podhrastovi Sarajevo
Bulgaria 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
Chile Instituto Nacional de Cancer Santiago
Croatia Clinical Hospital Dubrovnik
Croatia Clinical Hospital Osijek
Croatia Clinical Hospital Split Split
Croatia Clinic for Pulmonary Diseses "Jordanovac" Zagreb
Hungary St. George County Hospital Fejer County
Hungary University of Szeged Szeged
Hungary General Rehablitation and Medicinal Bath Hospital Szombathely
India Gujrat Cancer Research Institute Asarwa Ahmadabad
India Curie Centre of Oncology Bangalore
India Kidwai Memorial Institute of Oncology Bangalore Karnataka
India Jawaharlal Nehru Cancer Hospital and Research Centre Bhopal
India Apollo Speciality Hospital Chennai
India Indo American Institute of Oncology Hyderabaad
India MNJ Institute of Oncology Hyderabaad
India Yashoda Group of Hospitals Hyderabad
India SEAROC Cancer Center Jaipur
India Lakeshore Hospital and Research Center Kochin Kerala
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 Shatabdi Superspeciality Hospital Nasik Maharashtra
India Rajiv Gandhi Cancer Institute, Delhi New Delhi
India Sir Ganga Ram Hospital 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 Vishakhapatnam
Latvia Daugavas Hospital Daugavpils
Latvia Paul Stradins Clincial University Hospital Riga
Montenegro Special Hospital for Pulmonary Diseases Niksic
Poland Kujawsko-Pomorski Centre of Pulmonology Bydgoszcz
Poland NMP, Memorial Voyvodship Hospital Czestochowa
Poland Dr. Bieganski Memorial Regional Specialsitic Hospital Grudziadz
Poland Regional Hospital, Department of Pulmonary Diseases and Chemotherapy Krakow
Poland Independent Public Group for Tuberculosis and Lung Disease in Olsztyn Olsztyn
Poland Conservative Outpatient Oncology Department, Voyevodship Hospital in Plock Plock
Poland Department of Clinical Oncology, Wielkopolskie Centre of Lung Diseases and Tuberculosis Poznan
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 Dolnoslaskie Centre of Lung Diseases Wroclaw Dolnoslaskie
Poland Silesian Medical University in Katowice Zabrze Dolny Slask
Romania Baia Mare "Constantin Opris" County Emergency Hospital Baia Mare Maramures County
Romania Bucharest Institute of Oncology Bucharest
Romania IANULI Medconsult SRL Bucharest
Romania Prof. Dr. Ion Chircuta, Oncology Institute Cluj-Napoca
Romania Prof. Dr. Ion Chiricuta, Institute of Oncology Cluj-Napoca Cluj-Napoca Cluj
Romania Clinical Emergency County Hospital Constanta Constanta
Romania Medical Oncology Center Iasi Iasi
Romania Schuller Municipal Hospital Ploiesti-Medical Oncology Department Ploiesti
Romania Clinical County Hospital Sibiu
Romania Sf. loan cel Nou, Emergency County Hospital Suceava
Romania OncoMed Timisoara
Russian Federation Arkhangelsk Regional Clinical Oncology Center Arkhangelsk
Russian Federation Altai Regional Oncology Center Barnaul
Russian Federation Regional Oncology Center Birobidzhan Jewish Republic
Russian Federation Chelyabinsk Regional Oncology Center Chelyabinsk
Russian Federation City Hospital #1 Cherepovets
Russian Federation Chita Regional Oncology Center Chita
Russian Federation Sverdlovsk Regional Oncology Center Ekaterinburg
Russian Federation Regional Oncology Center Engels
Russian Federation Regional Oncology Center Irkutsk
Russian Federation Ivanovo Regional Oncology Center Ivanovo
Russian Federation Republican Clinical Oncology Center of the Republic of Udmurtia Izhevsk
Russian Federation Kaluga Regional Oncology Center Kaluga
Russian Federation Clinical Oncology Center Kazan Tatarstan Republic
Russian Federation Kazan Oncology Center Kazan Tatarstan Republic
Russian Federation Regional Clinical Oncology Center Khabarovsk
Russian Federation Regional Clinical Oncology Center Kirov
Russian Federation City Oncology Center Komsomolsk-na-Amure
Russian Federation Krasnodar Clinical Oncology Krasnodar
Russian Federation Regional Clinical Hospital #1 Krasnodar
Russian Federation Kurst Regional Oncology Center Kurst
Russian Federation Lipetsk Regional Oncology Center Lipetsk
Russian Federation Magnitogorsk Clinical Oncology Hospital Magnitogorsk
Russian Federation Blokhin Russian Oncology Research Center Moscow
Russian Federation Central Clinical Hospital and Outpatient Unit of the Medical Center under the Russian Presidential Administration Moscow
Russian Federation Semashko Central Clinical Hospital #2 under Russian Railways Moscow
Russian Federation Novorossiysk Oncology Center Novorossiysk
Russian Federation City Clinical Hospital #1 Novosibirsk
Russian Federation Medical Radiology Research Center under RAMS Obnninsk
Russian Federation Orel Oncology Center Orel
Russian Federation Orenburg Regional Clinical Oncology Center Orenburg
Russian Federation Regional Oncology Center Penza
Russian Federation Republican Oncology Center of the Ministry of Healthcare of Karelia Republic Petrozavodsk Karelia Republic
Russian Federation Pyatigorsk Affiliate of Stavropol Regional Clinical Oncology Center Pyatigorsk
Russian Federation Ogarev Mordovian State University Saransk
Russian Federation State Higher Education Institution Saratov State Medical University under the Federal Agency for Healthcare and Social Development Saratov
Russian Federation Oncology Center Sochi
Russian Federation City Clinical Oncology Center, Thoracic Oncology Department #6 St. Petersburg
Russian Federation Pavlov St. Petersburg State Medical University, Pulmonology Research Institute St. Petersburg
Russian Federation St. Petersburg City Multifield Hospital #2 St. Petersburg
Russian Federation St. Petersburg Pavlov State Medical University St. Petersburg
Russian Federation Komi Republican Oncology Center Syktyvkar Komi Republic
Russian Federation Tambov Regional Oncology Center Tambov
Russian Federation Tomsk Regional Oncology Center Tomsk
Russian Federation Tula Regional Oncology Center Tula
Russian Federation Ufa, Republican Oncology Center Ufa
Russian Federation Buryatia Republican Oncology Center Ulan-Ude Buryatia
Russian Federation Primorsky Regional Oncology Center Vladivostok
Russian Federation Volgograd Regional Clinical Oncology Center#1 Volograd
Russian Federation Voronezh Regional Clinical Oncology Center Voronezh
Russian Federation Regional Clinical Oncology Hospital Yaroslavl
Russian Federation Republican of Clinical Hospital, Mariy-El Republican Yoshkar-Ola
Serbia Clinic for Pulmonary Diseases and TBC Knez Selo
Serbia Institute for Pulmonary Diseases of Vijvodina Vijvodina
Ukraine 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 Ternopol
Ukraine Zaporozhye Regional Clinical Oncology Center Zaporozhye

Sponsors (1)

Lead Sponsor Collaborator
Poniard Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Belarus,  Bosnia and Herzegovina,  Bulgaria,  Chile,  Croatia,  Hungary,  India,  Latvia,  Montenegro,  Poland,  Romania,  Russian Federation,  Serbia,  Ukraine, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary overall survival death No
Secondary objective response rate progression No
Secondary disease control rate progression No
Secondary duration of response progression No
Secondary progression-free survival death No
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