Bevacizumab and Docetaxel in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

NCT00541099 | Completed Phase 2 Results DMC

• 3 other identifiers: CDR0000555019P30CA022453WSU-2007-053
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: 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. Drugs used in chemotherapy, such as docetaxel, also work in different ways to kill tumor cells or stop them from growing. Giving bevacizumab together with docetaxel may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel works in treating older patients with stage III or stage IV non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Survival

  6 months when treated with combination of Avastin and weekly docetaxel

Secondary Outcomes (4)

• Progression-free Survival

  6 months when treated with combination of Avastin and weekly docetaxel

• Overall Survival

  4 weeks after removal from study or until death

• Response Rate

  Every 8 weeks

• Toxicity According to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

  1st and 2nd week of each 21 day cycle, up to six cycles.

Study Arms (1)

Avastin & Docetaxel

EXPERIMENTAL

Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15

Biological: bevacizumab; Drug: docetaxel

Interventions

bevacizumab BIOLOGICAL

Avastin 10.0 mg/kg on days 1 and 15

Also known as: Avastin

Avastin & Docetaxel

docetaxel DRUG

Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15

Also known as: TAXOTERE®

Avastin & Docetaxel

Eligibility Criteria

• Age: 75 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed non-small cell lung cancer
• Stage III or IV disease
• Stage III disease allowed, provided the patient is not a candidate for concurrent chemotherapy and radiotherapy
• Mixed histology allowed, provided the biopsy has less than 50% squamous cell histology
• Measurable or evaluable disease

You may not qualify if:

• Squamous cell histology
• Evidence of cavitation in the tumor
• Tumors in close proximity to major blood vessels
• No active, untreated brain metastases
• More than 7 days since prior treatment for brain metastases AND no evidence of hemorrhage in the lesion
• Stable or declining dose of steroids allowed
• PATIENT CHARACTERISTICS:
• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Life expectancy \> 12 weeks
• Leukocytes ≥ 3,000/μL
• Absolute neutrophil count ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN (\< 5 times ULN if patients has liver metastases)
• Creatinine ≤ 1.5 times normal

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab; 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; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Limitations and Caveats

The increased use of pemetrexed in the front line setting affected accrual.

Results Point of Contact

• Title: Shirish Gadgeel, M.D.
• Organization: Barbara Ann Karmanos Cancer Institute

sgadgeel@med.umich.edu

(313) 576-8753

Study Officials

• Shirish M. Gadgeel, MD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 8, 2007
• Study Start: January 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 27, 2019
• Results First Posted: August 21, 2014

Record last verified: 2014-08

Locations

US (3)