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

This study has been completed.
Sponsor:
Information provided by:
Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00687817
First received: May 28, 2008
Last updated: March 23, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: bavituximab plus paclitaxel and carboplatin
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Peregrine Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to tumor progression, duration of response, overall survival and safety [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: June 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00687817

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

No publications provided

Responsible Party: A.J. Leyco, RN/Associate Director, Clinical Affairs, Peregrine Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00687817     History of Changes
Other Study ID Numbers: PPHM 0701
Study First Received: May 28, 2008
Last Updated: March 23, 2011
Health Authority: India: Drugs Controller General of India

Keywords provided by Peregrine Pharmaceuticals:
NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Paclitaxel
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014