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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Aptium Oncology Research Network.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by:
Aptium Oncology Research Network
ClinicalTrials.gov Identifier:
NCT00516100
First received: August 10, 2007
Last updated: January 14, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: bortezomib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Clinical Trial of Bortezomib (Velcade) + Pemetrexed (Alimta) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Aptium Oncology Research Network:

Primary Outcome Measures:
  • (Phase I)Maximum tolerated dose of bortezomib [ Time Frame: Within 6 three-week cycles (18 weeks) ] [ Designated as safety issue: Yes ]
  • (Phase II)determine response rate, time to progression, one-year survival, and overall survival rates [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 62
Study Start Date: January 2006
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: bortezomib
    MTD of bortezomib administered Days 1 and 8 plus 500 mg/m2 pemetrexed on day 1, every three weeks.
    Other Names:
    • Velcade (bortezomib)
    • Alimta (pemetrexed)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Patient has hypersensitivity to bortezomib, boron or mannitol.
  • Female patient is pregnant or breast-feeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516100

Locations
United States, California
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, United States, 90048
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, United States, 92262
California Pacific Medical Center
San Francisco, California, United States, 94115
United States, New Jersey
Trinitas Comprehensive Cancer Center
Elizabeth, New Jersey, United States, 07207
Sponsors and Collaborators
Aptium Oncology Research Network
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: Ronald B. Natale, MD Cedars-Sinai Outpatient Cancer Center
  More Information

No publications provided

Responsible Party: Marti McKinley, Aptium Oncology Research Network
ClinicalTrials.gov Identifier: NCT00516100     History of Changes
Other Study ID Numbers: 05LUN01
Study First Received: August 10, 2007
Last Updated: January 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Aptium Oncology Research Network:
NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Bortezomib
Pemetrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014