Bortezomib (Velcade) + Pemetrexed (Alimta) in Advanced NSCLC
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ClinicalTrials.gov Identifier: NCT00516100 |
Recruitment Status : Unknown
Verified January 2010 by Aptium Oncology Research Network.
Recruitment status was: Active, not recruiting
First Posted : August 14, 2007
Last Update Posted : January 15, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-small Cell Lung Cancer | Drug: bortezomib | Phase 1 Phase 2 |
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 |

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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516100
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 |
Principal Investigator: | Ronald B. Natale, MD | Cedars-Sinai Outpatient Cancer Center |
Responsible Party: | Marti McKinley, Aptium Oncology Research Network |
ClinicalTrials.gov Identifier: | NCT00516100 |
Other Study ID Numbers: |
05LUN01 |
First Posted: | August 14, 2007 Key Record Dates |
Last Update Posted: | January 15, 2010 |
Last Verified: | January 2010 |
NSCLC |
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 |