Carboplatin, Docetaxel, Bevacizumab, and Erlotinib Versus Chemotherapy Alone in Resected NSCLC

NCT ID: NCT00621049

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2014-02-28

Brief Summary

Multicenter randomized phase II trial to examine the safety and efficacy of carboplatin, docetaxel, bevacizumab followed by maintenance bevacizumab and erlotinib in patients with completely resected stage IB, II, and select III NSCLC.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Docetaxel/Carboplatin/Bevacizumab/Erlotinib

Group Type: EXPERIMENTAL

Docetaxel/Carboplatin/Bevacizumab/Erlotinib

Intervention Type: DRUG

Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1

Docetaxel should be administered before carboplatin.

After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:

Maintenance Treatment for patients in Cohort A:

Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily

Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity.

Docetaxel and Carboplatin

Group Type: ACTIVE_COMPARATOR

Docetaxel/Carboplatin

Intervention Type: DRUG

Adjuvant Treatment Cohort B:

Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1

Docetaxel should be administered before carboplatin.

Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment.

Interventions

Docetaxel/Carboplatin/Bevacizumab/Erlotinib

Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1

Docetaxel should be administered before carboplatin.

After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:

Maintenance Treatment for patients in Cohort A:

Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily

Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity.

Intervention Type: DRUG

Docetaxel/Carboplatin

Adjuvant Treatment Cohort B:

Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1

Docetaxel should be administered before carboplatin.

Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients must have histologically-confirmed non-small cell lung cancer (adenocarcinoma, squamous, large cell and undifferentiated). Mixed small cell and non-small histologies are excluded.

2. Patients with completely resected (R0) stage IB, II, and select III NSCLC. The following stages are eligible:

IB T2 N0 IIA T1 N1 IIB T2 N1 IIB T3 N0 IIIA T3 N1

• Bronchioalveolar carcinoma that presents as a single, solitary discrete nodule or mass may be included
• Patients determined to have N2 disease, that was not apparent radiologically preoperatively (and completely resected) can be included.

3. Complete surgical resection defined as the appropriate pulmonary parenchymal resection including lobectomy, bilobectomy, sleeve lobectomy, and pneumonectomy with histologically confirmed negative bronchial margins. Patients treated by segmentectomy or wedge resection are not eligible for this study. Additionally all patients must have had either a mediastinal node dissection or at least, sampling of 2 mediastinal nodal stations (levels 4,7,and 9 for right-sided tumors, and levels 5,6,7, and 9 for left-sided tumors are suggested.)

4. No evidence of metastatic disease

5. ANC >= 1500, platelets >= 100,000 and hemoglobin >= 10.0.

6. Total bilirubin <= ULN. AST and ALT and alkaline phosphatase must be WNL

7. Serum creatinine <= 1.5mg/dl (If greater than 1.5, the creatinine clearance, calculated according to the Cockroft-Gault formula, must be >= 50ml/min).

8. Patients may have had no previous chemotherapy, radiation therapy, angiogenesis inhibitor, or tyrosine kinase inhibitor for non-small cell lung cancer.

9. Patients must be able to understand the nature of this study and give written informed consent.

10. Age >= 18 years

11. Ability to start treatment between 8 and 12 weeks following surgery.

12. Ability to take oral medication.

Exclusion Criteria

1. Patients with preoperative radiologic evidence of N2 disease by either PET or CT scan (i.e. radiological evidence of metastasis to ipsilateral mediastinal and subcarinal nodes) that is confirmed as N2 disease histologically are excluded. - PLEASE SEE EXCEPTION in section 3.1.2 of protocol

2. Mixed small cell and non-small cell histologies

3. Pulmonary carcinoid tumors

4. Positive bronchial margins

5. History of prior malignancy within 5 years with the exception of skin cancer or cervical carcinoma in situ.

6. Women who are pregnant (positive pregnancy test) or breast-feeding. Subjects of childbearing potential or with partners of childbearing potential (women and men) must use effective birth control measures during treatment.

7. Treatment with a non-approved or investigational drug within 30 days before day 1 of trial treatment.

8. Patients with seizures not controlled with standard medical therapy.

9. Patients with active infection requiring parenteral antibiotics

10. Patients who have had major surgical procedure, open biopsy, or significant traumatic injury within 8 weeks of beginning study treatment or anticipation of need for major surgical procedure during the course of the study

11. Fine needle aspiration, core biopsy or other minor surgical procedure (excluding placement of a vascular access device) within 7 days of beginning study treatment.

12. Patients receiving thrombolytic therapy within 10 days of starting study treatment are also ineligible. Patients may receive prophylactic anticoagulation therapy, 1 mg coumadin daily for port clot prophylaxis.

13. Patients with proteinuria at screening as demonstrated by either:

• Urine protein creatinine (UPC) ratio >= 1.0 at screening 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 >= 1 g of protein in 24hours to be eligible).

14. Patients with serious nonhealing wound, ulcer, or bone fracture.

15. Patients with evidence of bleeding diathesis or coagulopathy.

16. Patients with history of hemoptysis defined as bright red blood of ½ teaspoon or more per episode) within 8 weeks prior to study treatment.

17. History of myocardial infarction or unstable angina within 6 months of beginning study treatment.

18. Inadequately controlled hypertension (defined as systolic blood pressure > 150 and /or diastolic blood pressure > 100 mmHg on antihypertensive medications).

19. New York Heart Association (NYHA) grade II or greater CHF.

20. Serious cardiac arrhythmia requiring medication.

21. Symptomatic peripheral vascular disease.

22. History of stroke or transient ischemic attack within 6 months prior to beginning bevacizumab.

23. Any prior history of hypertensive crisis or hypertensive encephalopathy.

24. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning study treatment.

25. ECOG Performance status > 1.

26. Peripheral neuropathy> grade 1.

27. Known hypersensitivity to any component of study drugs including platinum or to drugs formulated with polysorbate 80.

28. Impaired oral absorption.

29. Inability to comply with study and/or follow-up procedures.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Spigel, M.D.

Role: STUDY_CHAIR

SCRI Development Innovations, LLC

Locations

Northeast Alabama Medical Center

Anniston, Alabama, United States

Northeast Arkansas Clinic

Jonesboro, Arkansas, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Gulfcoast Oncology Associates

St. Petersburg, Florida, United States

Medical Oncology Associates of Augusta

Augusta, Georgia, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Wellstar Cancer Research

Marietta, Georgia, United States

Providence Medical Group

Terre Haute, Indiana, United States

RHHP/Hope Cancer Center

Terre Haute, Indiana, United States

Baptist Hospital East

Louisville, Kentucky, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Hematology Oncology Life Center

Alexandria, Louisiana, United States

Hematology Oncology Clinic, LLP

Baton Rouge, Louisiana, United States

Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

Jackson Oncology Associates

Jackson, Mississippi, United States

St. Louis Cancer Care

Chesterfield, Missouri, United States

Nebraska Methodist Cancer Center

Omaha, Nebraska, United States

Portsmouth Regional Hospital

Portsmouth, New Hampshire, United States

Hematology Oncology Associates of Northern NJ

Morristown, New Jersey, United States

New Mexico Oncology Hematology Consultants

Albuquerque, New Mexico, United States

Cancer Care of Western North Carolina

Asheville, North Carolina, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

Associates in Hematology Oncology

Chattanooga, Tennessee, United States

Chattanooga Oncology Hematology Associates

Chattanooga, Tennessee, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Peninsula Cancer Institute

Newport News, Virginia, United States

Countries

United States

Other Identifiers

US_IST_12218

Identifier Type: -

Identifier Source: secondary_id

AVF3923s

Identifier Type: -

Identifier Source: secondary_id

SCRI LUN 142

Identifier Type: -

Identifier Source: org_study_id