Study of Picoplatin Efficacy After Relapse (SPEAR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Poniard Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Poniard Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00465491
First received: April 23, 2007
Last updated: April 13, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Small Cell Lung Cancer
Drug: picoplatin
Other: best supportive care
Other: Best Supportive Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Poniard Pharmaceuticals:

Primary Outcome Measures:
  • overall survival [ Time Frame: death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • objective response rate [ Time Frame: progression ] [ Designated as safety issue: No ]
  • disease control rate [ Time Frame: progression ] [ Designated as safety issue: No ]
  • duration of response [ Time Frame: progression ] [ Designated as safety issue: No ]
  • progression-free survival [ Time Frame: death ] [ Designated as safety issue: No ]

Estimated Enrollment: 399
Study Start Date: April 2007
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Picoplatin
Drug: picoplatin
IV picoplatin 150mg/m2 q3wk
2
BSC
Other: best supportive care
best supportive care
Other: Best Supportive Care
Best Supportive Care

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465491

  Show 143 Study Locations
Sponsors and Collaborators
Poniard Pharmaceuticals
Investigators
Study Director: Dr. Hazel Breitz, M.D. Poniard Pharmaceuticals
  More Information

Publications:

Responsible Party: Hazel Breitz, MD, Poniard Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00465491     History of Changes
Other Study ID Numbers: 0601
Study First Received: April 23, 2007
Last Updated: April 13, 2009
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Poniard Pharmaceuticals:
refractory
chemotherapy
progressed
second-line treatment
small cell lung cancer
best supportive care
picoplatin

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on September 22, 2014