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Study of Picoplatin Efficacy After Relapse (SPEAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00465491
Recruitment Status : Unknown
Verified April 2009 by Poniard Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : April 25, 2007
Last Update Posted : April 14, 2009
Sponsor:
Information provided by:
Poniard Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE April 23, 2007
First Posted Date  ICMJE April 25, 2007
Last Update Posted Date April 14, 2009
Study Start Date  ICMJE April 2007
Estimated Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2009)
overall survival [ Time Frame: death ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2007)
overall survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2009)
  • objective response rate [ Time Frame: progression ]
  • disease control rate [ Time Frame: progression ]
  • duration of response [ Time Frame: progression ]
  • progression-free survival [ Time Frame: death ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2007)
  • objective response rate
  • disease control rate
  • duration of response
  • progression-free survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Picoplatin Efficacy After Relapse
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: picoplatin
    IV picoplatin 150mg/m2 q3wk
  • Other: best supportive care
    best supportive care
Study Arms  ICMJE
  • Experimental: 1
    Picoplatin
    Intervention: Drug: picoplatin
  • 2
    BSC
    Intervention: Other: best supportive care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 23, 2007)
399
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belarus,   Bosnia and Herzegovina,   Bulgaria,   Chile,   Croatia,   Hungary,   India,   Latvia,   Montenegro,   Poland,   Romania,   Russian Federation,   Serbia,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00465491
Other Study ID Numbers  ICMJE 0601
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hazel Breitz, MD, Poniard Pharmaceuticals, Inc.
Study Sponsor  ICMJE Poniard Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dr. Hazel Breitz, M.D. Poniard Pharmaceuticals
PRS Account Poniard Pharmaceuticals
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP