Study of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated Non Small-Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01160601
First received: July 8, 2010
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

This is a randomized, open-label, multicenter, phase 2 study comparing Paclitaxel/Carboplatin with or without bavituximab in patients that have previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC).


Condition Intervention Phase
Non-Squamous Non-Small Cell Lung Cancer
Drug: Paclitaxel / Carboplatin
Drug: bavituximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Phase 2 Trial of Paclitaxel/Carboplatin With or Without Bavituximab in Patients With Previously Untreated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Peregrine Pharmaceuticals:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: June 2010
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: paclitaxel/carboplatin plus bavituximab
Patients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve [AUC] 6) on Day 1 of each 21 day cycle for up to 6 cycles, in combination with 3 mg/kg bavituximab administered weekly.
Drug: Paclitaxel / Carboplatin
Patients will receive commercially available paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve [AUC] 6) on Day 1 of each 21 day cycle for up to 6 cycles.
Drug: bavituximab
Patients will receive 3 mg/kg bavituximab, administered weekly until progression or toxicity.
Active Comparator: paclitaxel/carboplatin
Patients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve [AUC] 6) on Day 1 of each 21 day cycle for up to 6 cycles.
Drug: Paclitaxel / Carboplatin
Patients will receive commercially available paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve [AUC] 6) on Day 1 of each 21 day cycle for up to 6 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 18 years of age with a life expectancy of at least 3 months.
  • Histologically or cytologically confirmed stage IIIB or stage IV non-squamous NSCLC that has not been previously treated with systemic chemotherapy.
  • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1).
  • Adequate hematologic, renal and hepatic function.
  • PT / INR ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN and D-dimer ≤ 3 × ULN.

Key Exclusion Criteria:

  • Squamous cell, small cell, or mixed histology.
  • Known history of bleeding diathesis or coagulopathy.
  • Cavitary tumors or tumors abutting large blood vessels.
  • Bleeding: Clinically significant bleeding, such as gross hematuria, GI bleeding and hemoptysis, within 12 months of Screening.
  • Venous thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism) within 6 months of Screening.
  • Ongoing therapy with oral or parenteral anticoagulants.
  • Concurrent estrogens, anti-estrogens or progesterone compounds.
  • Grade 2 or higher peripheral neuropathy.
  • Radiotherapy within 2 weeks preceding Study Day 1.
  • Symptomatic or clinically active brain metastases.
  • Major surgery within 4 weeks of Study Day 1.
  • Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease).
  • Symptomatic coronary artery disease, cerebrovascular accident,transient ischemic attack, myocardial infarction, or unstable angina pectoris within 6 months of Screening.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01160601

  Show 40 Study Locations
Sponsors and Collaborators
Peregrine Pharmaceuticals
  More Information

No publications provided

Responsible Party: Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01160601     History of Changes
Other Study ID Numbers: PPHM 1001
Study First Received: July 8, 2010
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India

Keywords provided by Peregrine Pharmaceuticals:
NSCLC
lung cancer
non small cell lung cancer
bavituximab
monoclonal antibody

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
Antibodies, Monoclonal
Carboplatin
Paclitaxel
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 16, 2014