Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer
A Phase II Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
1 other identifier
interventional
49
1 country
9
Brief Summary
The primary objective of this study is to determine the overall response rate (complete response + partial response) to a combination of bavituximab plus carboplatin and paclitaxel in patients with previously untreated locally advanced or metastatic non-small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer
Started Jun 2008
Shorter than P25 for phase_2 nonsmall-cell-lung-cancer
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedFirst Posted
Study publicly available on registry
June 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedMarch 24, 2011
March 1, 2011
2.1 years
May 28, 2008
March 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall response (complete response + partial response) to a combination of bavituximab plus carboplatin and paclitaxel in patients with previously untreated locally advanced or metastatic non-small-cell lung cancer
one year
Secondary Outcomes (1)
Time to tumor progression, duration of response, overall survival and safety
Approximately 1 year
Interventions
Weekly bavituximab dose of 3 mg/kg until disease progression, and up to 6 cycles of carboplatin at a dose of AUC=5 and paclitaxel 175 mg/m2 every 21 days (21-day cycles)
Eligibility Criteria
You may qualify if:
- Adults over age 18 years of age with a life expectancy of at least 3 months
- Histologically or cytologically confirmed non-small cell lung cancer at stage IIIB (with pleural effusion), stage IV, or recurrence
- Measurable disease on cross sectional imaging at least 2 cm in longest diameter (1 cm if measured by spiral CT)
- Adequate hematologic (ANC ≥ 1500 cells/µL; Hemoglobin ≥9 g/dL; platelets ≥100,000/µL and ≤500,000/µL ), renal (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min), and hepatic function (bilirubin ≤ 1.5 x ULN, ALT ≤ 3 x ULN, AST ≤ 3 x ULN)
- D-dimer ≤ 2 x ULN
You may not qualify if:
- Small cell or mixed histology
- Known history of bleeding diathesis or coagulopathy
- Any current evidence of clinically significant bleeding defined as gross hematuria, hemoptysis, or GI bleeding
- Any history of thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism)
- Prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy
- Radiotherapy within 2 weeks preceding Study Day 1
- Symptomatic or clinically active CNS disease or metastatic lesions
- Major surgery within 4 weeks of Study Day 1
- Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)
- Any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack
- A history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin. Anti-platelet agents are prohibited during the study.
- Requirement for chronic daily treatment with NSAIDs, anti-platelet drugs, or steroids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Apollo Hospital
Bannerghatta Rd, Banglore, 560 076, India
Kidwai Hospital
Munigowda Road, Banglore, 560 027, India
M S Ramaiah Hospital
New BEL Rd, Banglore, 560 054, India
Bangalore Institute of Oncology Speciality Centre
Sampangi Ram Nagar, Banglore, 560 027, India
Nizam's Institute of Medical Sciences
Panjagutta, Hyderabad, 500 082, India
Yashoda Hospital
Somājigūda, Hyderabad, 500 082, India
RCC Medical College
Trivandrum, Kerala, 695 011, India
Orchid Nursing Home
Phoolanbhaghan, Kolkata, India
Ruby Hall Clinic
Pune, Pune, 411-001, India
Related Publications (1)
Digumarti R, Bapsy PP, Suresh AV, Bhattacharyya GS, Dasappa L, Shan JS, Gerber DE. Bavituximab plus paclitaxel and carboplatin for the treatment of advanced non-small-cell lung cancer. Lung Cancer. 2014 Nov;86(2):231-6. doi: 10.1016/j.lungcan.2014.08.010. Epub 2014 Aug 24.
PMID: 25236982DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 28, 2008
First Posted
June 2, 2008
Study Start
June 1, 2008
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
March 24, 2011
Record last verified: 2011-03