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

March 23, 2011 updated by: Peregrine Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Pune, India, 411-001
        • Ruby Hall Clinic
    • Banglore
      • Bannerghatta Rd., Banglore, India, 560 076
        • Apollo Hospital
      • Munigowda Road, Banglore, India, 560 027
        • Kidwai Hospital
      • New BEL Rd, Banglore, India, 560 054
        • M S Ramaiah Hospital
      • Sampangi Ram Nagar, Banglore, India, 560 027
        • Bangalore Institute of Oncology Speciality Centre
    • Hyderabad
      • Panjagutta, Hyderabad, India, 500 082
        • Nizam's Institute of Medical Sciences
      • Somajiguda, Hyderabad, India, 500 082
        • Yashoda Hospital
    • Kerala
      • Trivandrum, Kerala, India, 695 011
        • RCC Medical College
    • Kolkata
      • Phoolanbhaghan, Kolkata, India
        • Orchid Nursing Home

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to tumor progression, duration of response, overall survival and safety
Time Frame: Approximately 1 year
Approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peregrine Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

May 28, 2008

First Submitted That Met QC Criteria

May 30, 2008

First Posted (Estimate)

June 2, 2008

Study Record Updates

Last Update Posted (Estimate)

March 24, 2011

Last Update Submitted That Met QC Criteria

March 23, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPHM 0701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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