Radiation Therapy, Bevacizumab, Paclitaxel, and Carboplatin in Treating Patients With Unresectable Stage IIIB or Stage IV Non-Small Cell Lung Cancer at High Risk for Hemoptysis Caused by Bevacizumab

NCT00387374 | Completed Phase 2

• 7 other identifiers: NCI-2012-02704CCC-PHII-78N01CM62208N01CM62201N01CM62203N01CM62209CDR0000504067
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

This phase II trial is studying the side effects and how well giving radiation therapy together with bevacizumab, paclitaxel, and carboplatin works in treating patients with unresectable stage IIIB or stage IV non-small cell lung cancer at high risk for hemoptysis caused by bevacizumab. Radiation therapy uses high-energy x-rays to kill tumor cells. It may also prevent hemoptysis caused by bevacizumab. 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 non-small cell lung cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with bevacizumab and chemotherapy may kill more tumor cells

Conditions

Adenosquamous Cell Lung Cancer; Drug/Agent Toxicity by Tissue/Organ; Hemoptysis; Squamous Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Safety of treatment as measured by the incidence of grade 3-5 hemoptysis, as assessed by NCI CTCAE version 3.0

  All toxicities will be tabulated.

  Up to 12 months after completion of treatment

Secondary Outcomes (3)

• Response rate according to RECIST

  Up to 12 months

• Overall survival

  Up to 12 months

• Progression-free survival defined as the duration of time from start of protocol treatment to time of progression or death according to RECIST

  Up to 2 years

Study Arms (2)

Stratum I (radiotherapy, bevacizumab, chemotherapy)

EXPERIMENTAL

Patients undergo prophylactic radiotherapy on days 1-5 and 8-12. Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 15. Patients also receive paclitaxel IV over 3 hours or carboplatin IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 36 (course 2).

Biological: bevacizumab; Drug: paclitaxel; Drug: carboplatin; Radiation: radiation therapy

Stratum II (radiotherapy, chemotherapy, bevacizumab)

EXPERIMENTAL

Patients undergo prophylactic radiotherapy and receive paclitaxel and carboplatin as in stratum I. Patients also receive bevacizumab IV over 30-90 minutes on day 15 (course 1). In both strata, treatment with paclitaxel, carboplatin, and bevacizumab repeats every 21 days for 5-6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response or stable disease may continue to receive single-agent bevacizumab every 21 days in the absence of disease progression or unacceptable toxicity.

Biological: bevacizumab; Drug: paclitaxel; Drug: carboplatin; Radiation: radiation therapy

Interventions

bevacizumab BIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

Stratum I (radiotherapy, bevacizumab, chemotherapy); Stratum II (radiotherapy, chemotherapy, bevacizumab)

paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol

Stratum I (radiotherapy, bevacizumab, chemotherapy); Stratum II (radiotherapy, chemotherapy, bevacizumab)

carboplatin DRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin

Stratum I (radiotherapy, bevacizumab, chemotherapy); Stratum II (radiotherapy, chemotherapy, bevacizumab)

radiation therapy RADIATION

Undergo radiotherapy

Also known as: irradiation, radiotherapy, therapy, radiation

Stratum I (radiotherapy, bevacizumab, chemotherapy); Stratum II (radiotherapy, chemotherapy, bevacizumab)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC)\* meeting the following criteria:
• Squamous cell or mixed squamous-nonsquamous histology with predominant squamous component (≥ 50% squamous) with a primary, unresected endobronchial lesion
• No small cell component
• Centrally located primary tumor, defined by the following:
• Primary tumor of any T stage within or touching the zone of the proximal bronchial tree
• Zone is defined as a 3-dimensional volume with a perimeter of 2 cm in each direction around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
• Any disease within this volume must not invade blood vessels determined by a contrast-enhanced CT scan evaluation of the entire thorax with thin slices (≤ 5 mm) through the area of central tumor bulk (i.e., no evidence of vessel invasion radiological evaluation)
• Stage IIIB (with malignant pleural effusion) or stage IV disease
• Patients with stage IIIB NSCLC without an effusion are eligible if they are not candidates for combined modality therapy with curative intent (i.e., radical chemoradiotherapy)
• At high risk for bevacizumab-associated hemoptysis
• Hemoptysis estimated as between 2.5 mL and 10 mL (largest volume of single episode of hemoptysis) in the past 2 months
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• No known brain metastases by contrast-enhanced CT scan or gadolinium-enhanced MRI of the brain
• No clinical or radiologic evidence of an existing or impending spinal cord compression
• ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

California Cancer Consortium

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Hemoptysis; Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab; Paclitaxel; Taxes; Carboplatin; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Lung Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

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; Economics; Health Care Economics and Organizations; Coordination Complexes; Therapeutics; Physical Phenomena

Study Officials

• Zelanna Goldberg

  California Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2006
• First Posted: October 13, 2006
• Study Start: October 1, 2006
• Primary Completion: June 1, 2007
• Last Updated: January 17, 2013

Record last verified: 2013-01