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

• ClinicalTrials.gov Identifier: NCT00516100
• Recruitment Status: Unknown
• First Posted: August 14, 2007
• Last Update Posted: January 15, 2010
• Sponsor: Aptium Oncology Research Network
• Collaborator: Millennium Pharmaceuticals, Inc.
• Information provided by: Aptium Oncology Research Network

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non-small Cell Lung Cancer	Drug: bortezomib	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 62 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: January 2006
• Estimated Primary Completion Date: January 2010
• Estimated Study Completion Date: August 2012

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. (Phase I)Maximum tolerated dose of bortezomib [ Time Frame: Within 6 three-week cycles (18 weeks) ]
2. (Phase II)determine response rate, time to progression, one-year survival, and overall survival rates [ Time Frame: one year ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Marti McKinley, Aptium Oncology Research Network
• ClinicalTrials.gov Identifier: NCT00516100
• Other Study ID Numbers: 05LUN01
• First Posted: August 14, 2007
• Last Update Posted: January 15, 2010
• Last Verified: January 2010

Keywords provided by Aptium Oncology Research Network:

NSCLC

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pemetrexed; Bortezomib; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors