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

Non-small Cell Lung Cancer Clinical Trial

Official title:

Phase I/II Clinical Trial of Bortezomib (Velcade) + Pemetrexed (Alimta) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00516100
• Other study ID #: 05LUN01
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: August 10, 2007
• Last updated: January 14, 2010
• Start date: January 2006
• Est. completion date: August 2012

Study information

• Verified date: January 2010
• Source: Aptium Oncology Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: August 2012
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Trinitas Comprehensive Cancer Center	Elizabeth	New Jersey
United States	Cedars-Sinai Outpatient Cancer Center	Los Angeles	California
United States	Comprehensive Cancer Center at Desert Regional Medical Center	Palm Springs	California
United States	California Pacific Medical Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Aptium Oncology Research Network	Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(Phase I)Maximum tolerated dose of bortezomib		Within 6 three-week cycles (18 weeks)	Yes
Primary	(Phase II)determine response rate, time to progression, one-year survival, and overall survival rates		one year	No