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TERMINATEDPHASE2

VELCADE in Previously Treated Patients With Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma With BAC Features

A Multicenter, Open-Label, Phase 2 Study of VELCADE (Bortezomib) for Injection in Previously Treated Patients With Stage IIIB and IV Bronchioloalveolar Carcinoma and Adenocarcinoma With Bronchioloalveolar Features

NCT00117351•Millennium Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

This study will evaluate the safety and efficacy of VELCADE in patients with previously treated stage IIIB and IV bronchioloalveolar carcinoma and adenocarcinoma with bronchioloalveolar features.

Detailed Description

Bronchioloalveolar carcinoma (BAC) and adenocarcinoma with bronchioloalveolar features are distinct subtypes of non-small-cell lung cancer which are difficult to treat in advanced stages. This study will determine the safety and efficacy of VELCADE therapy in patients with advanced BAC or adenocarcinoma with BAC features who have failed epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have histologically or cytologically confirmed BAC or adenocarcinoma with BAC features.
•Have stage IIIB (malignant pleural effusion) or stage IV disease.
•Have progressed on or after receipt of 1 to 2 prior lines of chemotherapy, one of which must be an EGFR TKI (Iressa or Tarceva). Adjuvant chemotherapy will NOT be counted as a prior line of therapy.
•Have radiographic documentation of progressive disease (PD) as determined by the investigator.
•Have measurable disease by RECIST.
•Are 18 years of age or older.
•Have a life expectancy greater than 3 months.
•Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
•Are able to provide written informed consent in accordance with all applicable regulations and follow the study procedures.
•Patients must be capable of understanding the investigational nature and potential risks and benefits.

Exclusion Criteria

•Have had chemotherapy (or an EGFR TKI) 4 weeks prior to enrollment.
•Have peripheral neuropathy of Grade 2 or greater intensity, as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 3.0).
•Have been previously treated with VELCADE.
•Have experienced myocardial infarction within 6 months prior to enrollment or have New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
•Have had radiation therapy within 4 weeks prior to enrollment.
•Have had monoclonal antibody therapy within 4 weeks prior to enrollment.
•Have had any major surgery within 4 weeks prior to enrollment.
•Have inadequate organ function at the Screening visit as defined by laboratory testing
•Have symptomatic brain metastases or brain metastases that have not responded to radiation therapy, local or systemic chemotherapy, or were not completely resected by stereotactic surgery or other surgical modalities, or have significant post treatment brain edema.
•Have uncontrolled active systemic infection requiring treatment.
+7 more criteria

Locations (1)

Swedish Cancer Institute

Seattle, Washington, United States

Key Dates

Start Date

April 1, 2005

Primary Completion Date

June 1, 2007

Completion Date

July 1, 2007

Last Updated

February 17, 2011

Conditions

Carcinoma, Non-Small-Cell LungAdenocarcinoma, Bronchiolo-Alveolar

Interventions

VELCADE

DRUG

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

NCT06667908

Carcinoma, Non-Small-Cell Lung

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RECRUITING

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

NCT04165798

Carcinoma, Non-Small-Cell Lung

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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VELCADE in Previously Treated Patients With Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma With BAC Features

Inclusion Criteria

Exclusion Criteria

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

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