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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome 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

Outcome Time Frame:

one year

Safety Issue:

No

Authority:

India: Drugs Controller General of India

Study ID:

PPHM 0701

NCT ID:

NCT00687817

Start Date:

June 2008

Completion Date:

July 2010

Related Keywords:

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

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