Paclitaxel, Bevacizumab and Pemetrexed in Patients With Untreated, Advanced Non-Small Cell Lung Cancer Using Web-Based Data Collection, Patient Self-Reporting of Adverse Effects and Automated Response Assessment

NCT00807573 | Completed Phase 2 Results DMC

• 1 other identifier: 08-109
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to determine the percentage of patients with non-small cell lung cancer that will experience a shrinkage of their tumors following treatment with three medications given together: paclitaxel, pemetrexed (Alimta®), and bevacizumab (Avastin®). Each of these medications has been approved by the FDA for patients that have not received any treatment for their lung cancer. This study is designed to study the effects of all three drugs given at the same time. Each of these medications has been studied in lung cancer and is commercially available. Paclitaxel and pemetrexed are traditional chemotherapy drugs. Bevacizumab is a monoclonal antibody, which means that it attaches to a specific target. Bevacizumab attaches to a protein in the blood stream called Vascular Endothelial GrowthFactor (VEGF). VEGF helps tumors grow new blood vessels to feed themselves, and bevacizumab is thought to help block this new growth of blood vessels and starve the tumors of the nutrients they need.

Conditions

Lung Cancer

Keywords

BEVACIZUMAB (AVASTIN); PEMETREXED (ALTIMA); TAXOL (PACLITAXEL); 08-109

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (CR + PR by RECIST) Paclitaxel, Pemetrexed, and Bevacizumab in Patients With Advanced Non-Small Lung Cancer Who Have Received no Prior Treatment for Metastatic Disease.

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  2 years

Study Arms (1)

Paclitaxel, Bevacizumab & Pemetrexed

EXPERIMENTAL

During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m\^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m\^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15

Drug: Paclitaxel; Drug: Pemetrexed; Drug: Bevacizumab

Interventions

Paclitaxel DRUG

Day 1: Paclitaxel (90 mg/m\^2 over 60 minutes) Day 15: Paclitaxel (90 mg/m\^2 over 60 minutes)

Paclitaxel, Bevacizumab & Pemetrexed

Pemetrexed DRUG

Day 1: Pemetrexed (500 mg/m\^2 over 10 minutes) Day 15 Pemetrexed (500 mg/m2 over 10 minutes)

Paclitaxel, Bevacizumab & Pemetrexed

Bevacizumab DRUG

Day 1:Bevacizumab (10 mg/kg over 20 minutes) Day 15: Bevacizumab (10 mg/kg over 20 minutes)

Paclitaxel, Bevacizumab & Pemetrexed

Eligibility Criteria

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

You may qualify if:

• Pathologically confirmed Non-Small Cell Lung Cancer at MSKCC
• Clinical stage IIIB or IV.
• Measurable disease as per RECIST
• Greater than 6 months since receiving neo-adjuvant or adjuvant chemotherapy for Non-Small Cell Lung Cancer.
• Age ≥ 18 years.
• Karnofsky performance status of ≥ to 70.
• Marrow and organ function as follows:
• WBC ≥ to 4000/mm3
• Platelets ≥ to 160,000
• Bilirubin ≤ to 1.2mg/dL
• Creatinine clearance ≥ to 40mL/min
• AST and/or /ALT ≤ 37 Units/L (if one of these elevated, must be ≤ 2.5 ULN)
• Systolic blood pressure ≤ to 150mmHg or diastolic blood pressure ≤ to 100 mmHg).
• The subject is able to read and comprehend English text from a computer screen.
• Women of childbearing potential and sexually active men enrolled in the study must agree to practice effective contraception.

You may not qualify if:

• Squamous cell carcinoma.
• Prior treatment with paclitaxel, pemetrexed or bevacizumab for NSCLC.
• Prior systemic anticancer therapy for advanced NSCLC.
• Symptomatic brain metastases with evidence of hemorrhage.
• Radiation therapy to greater than 25% of the bone marrow within 30 days of starting treatment.
• Peripheral neuropathy greater than grade 1.
• Malignancies within the past 5 years other than non-melanoma skin cancer.
• Patients with other serious medical illnesses including, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
• History of hemoptysis.
• History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess.
• History of myocardial infarction or stroke within 6 months prior to enrollment.
• Pregnancy or lactation.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (5)

Memorial Sloan-Kettering at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan-Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan-Kettering at Mercy Medical Center

Rockville Centre, New York, United States

Location

Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital

Sleepy Hollow, New York, United States

Location

Related Publications (2)

• Basch E, Wood WA, Schrag D, Sima CS, Shaw M, Rogak LJ, Kris MG, Shouery M, Bennett A, Atkinson T, Pietanza MC. Feasibility and clinical impact of sharing patient-reported symptom toxicities and performance status with clinical investigators during a phase 2 cancer treatment trial. Clin Trials. 2016 Jun;13(3):331-7. doi: 10.1177/1740774515615540. Epub 2015 Nov 4.

  PMID: 26542025 DERIVED

• Pietanza MC, Basch EM, Lash A, Schwartz LH, Ginsberg MS, Zhao B, Shouery M, Shaw M, Rogak LJ, Wilson M, Gabow A, Latif M, Lin KH, Wu Q, Kass SL, Miller CP, Tyson L, Sumner DK, Berkowitz-Hergianto A, Sima CS, Kris MG. Harnessing technology to improve clinical trials: study of real-time informatics to collect data, toxicities, image response assessments, and patient-reported outcomes in a phase II clinical trial. J Clin Oncol. 2013 Jun 1;31(16):2004-9. doi: 10.1200/JCO.2012.45.8117. Epub 2013 Apr 29.

  PMID: 23630218 DERIVED

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Paclitaxel; Pemetrexed; Bevacizumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Maria Pietanza, Assistant Attending
• Organization: Memorial Sloan Kettering Cancer Center

PietanzM@mskcc.org

+1646-888-4203

Study Officials

• Maria Pietanza, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: December 11, 2008
• First Posted: December 12, 2008
• Study Start: December 1, 2008
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: December 30, 2015
• Results First Posted: December 30, 2015

Record last verified: 2015-11

Locations

US (5)