Docetaxel, Carboplatin, and Bevacizumab in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Can Be Removed By Surgery

NCT00293332 | Terminated Phase 2 DMC

• 4 other identifiers: CDR0000455640UCSF-04652UCSF-IIT-12198UCSF-H5535-25047-01A
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving docetaxel and carboplatin together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving docetaxel and carboplatin together with bevacizumab works in treating patients with stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Clinical response rate by CT scan after 3 courses of induction treatment

  After 3 cycles of induction treatment

Secondary Outcomes (10)

• Pathologic response rate after 3 courses of induction treatment

  After 3 cycles of induction treatment

• Resectability rate after 3 courses of induction treatment

  After 3 cycles of induction treatment

• Median survival at 2 years after surgery

  2 years after surgery

• Safety after 3 courses of induction treatment

  After 3 cycles of induction treatment

• Overall survival at 2 years after surgery

  2 years after surgery

Interventions

bevacizumab BIOLOGICAL

Neoadjuvant therapy with 15 mg/kg, IV on Day 1 of each 21 day cycle for the first 2 cycles.

Also known as: Avastin

carboplatin DRUG

Neoadjuvant therapy, AUC 6, IV on day 1 of each 21 day cycle for 3 cycles.

Also known as: Paraplatin

docetaxel DRUG

Neoadjuvant therapy, 75 mg/m2, IV on day 1 of each 21 day cycle for 3 cycles.

Also known as: Taxotere

conventional surgery PROCEDURE

Standard surgery after 3 cycles of neoadjuvant therapy with docetaxel, carboplatin, and bevacizumab. Bevacizumab is given for the first 2 cycles only.

Also known as: Resection

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer * No squamous cell carcinoma * No histology in close proximity to a major vessel * Resectable stage IB-IIIA disease * No CNS or brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL * Bilirubin normal * Creatinine ≤ 1.5 mg/dL * Urine protein:creatinine \< 1.0 * Alkaline phosphatase (AP), AST, and ALT must meet 1 of the following criteria: * AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN) * AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN * AP ≤ 5 times ULN AND AST and ALT normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months after completion of study treatment * Adequate pulmonary and cardiovascular function to tolerate surgical resection * No cavitation or history of hemoptysis (i.e., bright red blood ≥ ½ teaspoon) * No existing peripheral neuropathy ≥ grade 1 * No known history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 * No history of serious systemic disease, including any of the following: * Myocardial infarction within the past 6 months * Uncontrolled hypertension (i.e., blood pressure \> 150/110 mm Hg on medication) * Unstable angina * New York Heart Association class II-IV congestive heart failure * Unstable symptomatic arrhythmia requiring medication * Patients with chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) are eligible * Clinically significant peripheral vascular disease (i.e., grade II or higher) * No history of significant neurological or psychiatric condition * No known active infection within the past 14 days * No serious, nonhealing wound, ulcer, or bone fracture * No evidence of bleeding diathesis or coagulopathy * No stroke within the past 6 months * No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days * No other serious illness or medical condition * No active infection * No other currently active malignancy except nonmelanoma skin cancer * Malignancies for which therapy has been completed and are considered to have ≤ 30% chance of risk of relapse are not considered active PRIOR CONCURRENT THERAPY: * No prior chemotherapy or VEGF inhibitor * No prior (i.e., within the past 4 weeks), concurrent, or anticipated participation in another experimental drug study except a Genentech-sponsored bevacizumab cancer study * No major surgical procedure, open biopsy, or significant traumatic injury within the past 28 days * No anticipation for major surgical procedure during study treatment * No fine-needle aspiration or core biopsy within 7 days prior to study entry * No concurrent full-dose anticoagulation * No other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy for this cancer

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab; Carboplatin; Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Sarita Dubey, MD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2006
• First Posted: February 17, 2006
• Study Start: December 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: April 1, 2007
• Last Updated: February 9, 2011

Record last verified: 2007-06

Locations

US (1)