A Study of Cisplatin + Pemetrexed + Avastin as First-Line Therapy

NCT00998166 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: AAAB9652
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

In the past, patients with advanced lung cancer who were inoperable underwent chemotherapy with one or more chemotherapeutic agents. More recently, novel new agents targeting specific enzymes or pathways responsible for cell division have been developed and clinicians have begun to utilize various combinations of these drugs with standard chemotherapeutic agents for the treatment of NSCLC. Some of these approaches have demonstrated a small but significant increase in survival among patients with advanced disease. Because a recently completed Phase 3 study of bevacizumab + Taxol/Carboplatin in first line NSCLC therapy demonstrated a 23% improvement in median survival, it would be appealing to see if a regimen of bevacizumab/ cisplatin/Alimta would also demonstrate a similar, or perhaps better, response rate.

Conditions

Non-Small Cell Lung Cancer

Keywords

NSCLC

Outcome Measures

Primary Outcomes (1)

• Prevalence of Progression Free Survival (PFS)

  PFS defined as the time from the date of the first dose to the first date of disease progression or death.

  Up to 1 year

Study Arms (1)

Pemetrexed, Cisplatin, Bevacizumab

EXPERIMENTAL

Chemotherapy infusion on Day 1 of a 3-week cycle

Drug: Pemetrexed; Drug: Cisplatin; Drug: Bevacizumab

Interventions

Pemetrexed DRUG

1. Pre-hydration for 1-1/2 hours at 250 ml/hour 2. Pemetrexed 500 mg/m2 IV over 10 minutes 3. Return to hydration for 30 minutes at 250 ml/hour

Also known as: Alimta

Pemetrexed, Cisplatin, Bevacizumab

Cisplatin DRUG

4\. Cisplatin 75mg/m2 IV over 60-120 minutes

Also known as: No brands available

Pemetrexed, Cisplatin, Bevacizumab

Bevacizumab DRUG

5\. Bevacizumab 15mg/kg IV over 90 minutes

Also known as: Avastin

Pemetrexed, Cisplatin, Bevacizumab

Eligibility Criteria

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

You may qualify if:

• Have stage IIIB (malignant pleural or pericardial effusion) or stage IV disease.
• Be chemotherapy naïve.
• Have measurable disease by RECIST, defined as at least 1 lesion that can be accurately measured in at least 1 dimension as \>20 mm with conventional techniques or \>10 mm with spiral CT scan; the longest diameter is to be recorded.
• Are 18 years of age or older.
• Have a life expectancy greater than 3 months.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Are able to provide written informed consent in accordance with all applicable regulations and follow the study procedures. Patients must be capable of understanding the investigational nature, potential risks and benefits of the study.
• The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Alimta and the ability to take folic acid, Vitamin B12 and dexamethasone according to protocol.

You may not qualify if:

• Have had prior chemotherapy (or an epidermal growth factor receptor (EGFR TKI) for treatment of advanced disease
• Intrathoracic lung carcinoma of squamous cell histology
• History of hemoptysis (bright red blood of 1/2 teaspoon or more per episode) within 1 month prior to study enrollment.
• Current, ongoing treatment with full-dose warfarin or its equivalent (i.e., unfractionated and/or low molecular weight heparin).
• Current or recent (within 10 days of enrollment) use of aspirin (\>325 mg/day) or chronic use of other NSAIDs.
• Cardiovascular concerns.
• Have had radiation therapy within 2 weeks prior to enrollment.
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study.
• Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0.
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1.
• Serious, non-healing wound, ulcer, or bone fracture.
• Have inadequate organ function at the Screening visit.
• Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).
• Have uncontrolled active systemic infection requiring treatment.
• Have had treatment for a cancer other than NSCLC within 5 years prior to enrollment, with the exception of basal cell carcinoma or cervical cancer in situ.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (2)

North Shore University Hospital

Lake Success, New York, 11042, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Cisplatin; Bevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Mark Stoopler, MD
• Organization: Columbia University

mbs5@cumc.columbia.edu

212-305-8230

Study Officials

• Mark Stoopler, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• 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: SPONSOR

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: October 20, 2009
• Study Start: June 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: July 30, 2024
• Results First Posted: July 30, 2024

Record last verified: 2024-07

Locations

US (2)