Phase II Avastin Trial for Stage IIIB/IV NSCLC

NCT00766246 | Terminated Phase 2 DMC

• 1 other identifier: PSHCI 08-009
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized, open-label, multicenter study in 160 patients in first line treatment and 114 in second line treatment with advanced or metastatic NSCLC (Stage IIIB/IV).

Conditions

Non-small Cell Lung Cancer Stage IIIB; Non-small Cell Lung Cancer Stage IV

Keywords

Non-Small Cell Lung Cancer; Advanced Non-Small Cell Lung Cancer; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) of bevacizumab and pemetrexed compared to pemetrexed monotherapy during second-line treatment of Stage IIIB or IV NSCLC

  Duration of study

Secondary Outcomes (5)

• Overall Survival (OS)

  Duration of the study

• Objective tumor response (objective response rate [ORR]) in second-line treatment

  Duration of the study

• Progression-free survival (PFS) in first-line and maintenance treatment

  Duration of the study

• Objective tumor response (objective response rate [ORR]) in first-line and maintenance treatment

  Duration of the study

• Treatment safety in first-line, maintenance and second-line treatment

  Duration of the study

Study Arms (2)

First-line

EXPERIMENTAL

Carboplatin, docetaxel, bevacizumab Open-label, single arm with treatment period up to 6 cycles. Patients completing a total of 2 to 6 cycles of first-line without disease progression will be eligible for maintenance.

Drug: bevacizumab; Drug: docetaxel; Drug: carboplatin

Maintenance

EXPERIMENTAL

Bevacizumab Open-label, single arm with treatment period up to 18 cycles.

Drug: bevacizumab

Interventions

bevacizumab DRUG

15 mg/kg administered in 21 day cycles on day 1 of each cycle for first-line and maintenance

Also known as: Avastin

First-line; Maintenance

docetaxel DRUG

75 mg/m2 administered in 21-day cycles on day 1 of each cycle for first line treatment

Also known as: Taxotere

First-line

carboplatin DRUG

AUC=6 administered in 21-day cycles on day 1 of each cycle for first-line treatment

Also known as: Paraplatin

First-line

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Histologically or cytologically confirmed stage IIIB with malignant pleural effusion or stage IV NSCLC except squamous-cell carcinoma
• Measurable disease defined by RECIST
• Adequate organ function:
• Absolute neutrophil count ≥ 1.5 x 10(9)/L
• Hemoglobin ≥ 9.0 g/dL
• Platelets ≥ 100 x 10(9)/L
• Hepatic enzyme levels: AST and ALT and Alkaline Phosphatase must be within range allowing for eligibility. In determining eligibility, the more abnormal of the two values (AST or ALT) should be used according to table listed in the protocol
• Bilirubin ≤ ULN
• Serum Creatinine ≤ 1.5 mg/dL (or creatinine clearance ≥ 60mL/min)
• Urine protein/creatinine ratio \< 1.0 OR urine dipstick for proteinuria \< 2 + (patients discovered to have ≥ 2 + proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤1g of protein in 24 hours to be eligible)
• INR ≤ 1.5
• PTT ≤ ULN
• ECOG Performance Status 0-1
• Estimated survival of ≥ 12 weeks

You may not qualify if:

• Prior chemotherapy for advanced NSCLC
• Neoadjuvant or adjuvant treatment within six (6) months of registration
• Prior radiation therapy within three (3) weeks of registration; all side effects must have resolved by registration
• Prior treatment with an investigational or marketed agent that acts by antiangiogenesis mechanisms
• Large ( \> 4 cm) centrally located lesions or large lesions in close proximity to major blood vessels unless treated with palliative radiation
• Brain metastases or leptomeningeal disease, except for patients who have had a resection and/or completed a course of cranial irradiation, have no worsening CNS symptoms, and have discontinued all corticosteroids for that indication for at least one (1) month prior to registration
• History of gross hemoptysis (defined as bright red blood of at least ½ teaspoon or 2.5 mL per episode) within three (3) months of registration unless definitively treated with surgery, radiation, arteriographic embolization, or endobronchial interventions at least four (4) weeks prior to registration
• Presence of cavitory lesion
• Presence of squamous histology (mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible; sputum cytology alone is not acceptable)
• Peripheral neuropathy \> grade 1
• Major surgery, open biopsy or significant traumatic injury within four (4) weeks of registration or anticipation of need for major surgical procedure during the course of the study
• Minor surgical procedures, fine needle aspirations or core biopsies within one (1) week prior to registration
• Current, ongoing therapeutic anticoagulation with full-dose warfarin or its equivalent
• Current or recent (within ten \[10\] days of the first dose of study treatment) use of aspirin (at least 325 mg/day) or other NSAIDs with anti-platelet activity or treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix), or cilostazol (Pletal)
• History of prior malignancy within the past three (3) years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or treated localized prostate cancer with a current PSA of \< 1.0 mg/dL on two successive evaluations, at least three (3) months apart, with the most recent evaluation no more than four (4) weeks prior to registration

Sponsors & Collaborators

• Pharmatech: lead
• Genentech, Inc.: collaborator
• Sanofi: collaborator

Related Links

• Pharmatech's Active Clinical Trials

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Bevacizumab; Docetaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Chandra P Belani, MD

  Penn State Milton S. Hershey Medical Center, Penn State College of Medicine, Penn State Hershey Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 3, 2008
• Study Start: October 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 19, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share