Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687817
• Other study ID #: PPHM 0701
• Status: Completed
• Phase: Phase 2
• First received: May 28, 2008
• Last updated: March 23, 2011
• Start date: June 2008
• Est. completion date: July 2010

Study information

• Verified date: March 2011
• Source: Peregrine Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• bavituximab plus paclitaxel and carboplatin
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)

Locations

Country	Name	City	State
India	Apollo Hospital	Bannerghatta Rd.	Banglore
India	Kidwai Hospital	Munigowda Road	Banglore
India	M S Ramaiah Hospital	New BEL Rd	Banglore
India	Nizam's Institute of Medical Sciences	Panjagutta	Hyderabad
India	Orchid Nursing Home	Phoolanbhaghan	Kolkata
India	Ruby Hall Clinic	Pune
India	Bangalore Institute of Oncology Speciality Centre	Sampangi Ram Nagar	Banglore
India	Yashoda Hospital	Somajiguda	Hyderabad
India	RCC Medical College	Trivandrum	Kerala

Sponsors (1)

Lead Sponsor	Collaborator
Peregrine Pharmaceuticals

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to tumor progression, duration of response, overall survival and safety		Approximately 1 year	No