Bortezomib (Velcade) + Pemetrexed (Alimta) in Advanced NSCLC

NCT00516100 | Unknown Phase 1

• 1 other identifier: 05LUN01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 4

Brief Summary

Pemetrexed is an FDA-approved treatment for advanced lung cancer but the response rate is still very low. Bortezomib is currently approved to treat myeloma in patients who have already been treated. Currently, multiple studies are actively investigating how well bortezomib works with other drugs. This study is testing how much bortezomib can be given to advanced lung cancer patients who have already received one treatment. This study will also see how well bortezomib and pemetrexed work together to treat lung cancer patients.

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC

Outcome Measures

Primary Outcomes (2)

• (Phase I)Maximum tolerated dose of bortezomib

  Within 6 three-week cycles (18 weeks)

• (Phase II)determine response rate, time to progression, one-year survival, and overall survival rates

  one year

Interventions

bortezomib DRUG

MTD of bortezomib administered Days 1 and 8 plus 500 mg/m2 pemetrexed on day 1, every three weeks.

Also known as: Velcade (bortezomib), Alimta (pemetrexed)

Eligibility Criteria

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

You may qualify if:

• Unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC who have received one prior platinum-based chemotherapy regimen.
• One prior treatment with any biologically targeted agent is acceptable
• Stable, previously treated, brain metastases are allowed if clinically stable without steroid treatment for 10 days.
• ECOG performance status of 0 or 1.
• Measurable and/or evaluable indicator lesion(s).
• Adequate hematologic, renal and hepatic function
• Patient is of a legally consenting age
• Patient has a life-expectancy \>2 months.
• Voluntary written informed consent before performance of any study-related procedure
• Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control for the duration of the study.
• Male patient agrees to use an acceptable method for contraception for the duration of the study.

You may not qualify if:

• Prior treatment with pemetrexed (Alimta) or Bortezomib (Velcade).
• Patient was treated for another cancer within 3 years before enrollment, with the exception of basal cell carcinoma or cervical cancer in situ.
• Peripheral neuropathy NCI grade \> 2.
• Symptomatic or uncontrolled brain metastasis.
• Radiation therapy to major bone marrow (\> 10% of bone marrow) areas or to target lesions within 30 days prior to study entry.
• Patient has received other investigational drugs with 14 days before enrollment.
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• Any systemic therapy within 21 days prior to study entry.
• Patient known to be human immunodeficiency virus (HIV)-positive.
• Patient had a significant cardiac event within 6 months of enrollment
• History of arrhythmia
• Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age.
• QT prolongation with other medications that required discontinuation of that medication.
• Presence of left bundle branch block (LBBB).
• QTc ≥480 msec or greater on screening ECG.

Sponsors & Collaborators

• Aptium Oncology Research Network: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (4)

Cedars-Sinai Outpatient Cancer Center

Los Angeles, California, 90048, United States

Location

Comprehensive Cancer Center at Desert Regional Medical Center

Palm Springs, California, 92262, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Trinitas Comprehensive Cancer Center

Elizabeth, New Jersey, 07207, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Bortezomib; Pemetrexed

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)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Ronald B. Natale, MD

  Cedars-Sinai Outpatient Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: August 10, 2007
• First Posted: August 14, 2007
• Study Start: January 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: August 1, 2012
• Last Updated: January 15, 2010

Record last verified: 2010-01

Locations

US (4)