Clinical trial NCT00687817: Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC
Lead sponsor: Peregrine Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-06-02
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: one year
Secondary outcomes:
measure: Time to tumor progression, duration of response, overall survival and safety
timeFrame: Approximately 1 year
Other outcomes:
Locations:
city: Bannerghatta Rd.
country: India
facility: Apollo Hospital
state: Banglore
city: Munigowda Road
country: India
facility: Kidwai Hospital
state: Banglore
city: New BEL Rd
country: India
facility: M S Ramaiah Hospital
state: Banglore
city: Sampangi Ram Nagar
country: India
facility: Bangalore Institute of Oncology Speciality Centre
state: Banglore
city: Panjagutta
country: India
facility: Nizam's Institute of Medical Sciences
state: Hyderabad
city: Somajiguda
country: India
facility: Yashoda Hospital
state: Hyderabad
city: Trivandrum
country: India
facility: RCC Medical College
state: Kerala
city: Phoolanbhaghan
country: India
facility: Orchid Nursing Home
state: Kolkata
city: Pune
country: India
facility: Ruby Hall Clinic
Study officials:
References:
citation: 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.