- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00714246
Bortezomib (PS-341) in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer
Phase I/II Study of Bortezomib (PS-341) in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A chemotherapy efficacy plateau' has been reached for the treatment of patients with advanced or metastatic non-small cell lung cancer. Platinum-based two-drug combination is considered the current standard of care for the treatment of advanced NSCLC. There is a need to develop novel regimens to improve the outcome for patients with advanced NSCLC. The combination of carboplatin and docetaxel is effective for therapy of advanced NSCLC. This combination results in improved survival and quality of life for patients with advanced NSCLC. Docetaxel exhibits preclinical synergy with bortezomib.
The trial was intended to be a phase I/II study to define the maximum tolerated dose of bortezomib that can be administered in combination with docetaxel and carboplatin and subsequently evaluate the efficacy of the regimen for patients with advanced NSCLC. However, the trial never moved past the phase I portion of the study and was terminated early.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically/cytologically confirmed stage IIIB (pleural or pericardial effusion) or stage IV NSCLC
- Age > 18 years
- ECOG PS < 2
- No prior chemotherapy
- Measurable disease
- Signed informed consent
- Adequate bone marrow function
- Adequate renal function
- Adequate hepatic function
Exclusion Criteria:
- Untreated clinically active brain metastasis
- Radiotherapy within 2 weeks prior to initiation of protocol therapy
- Treatment with any investigational therapy within 4 weeks prior to enrollment
- History of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma on situ of the cervix) within the last 5 years
- Patients in their reproductive age group should use an effective method of birth control. Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter. Patients who are breast-feeding will be excluded from the study. Women of childbearing potential must have a negative pregnancy test.
- Major surgery within 3 weeks prior to enrollment
- Use of immunosuppressive agents including systemic corticosteroids within 4 weeks prior to enrollment (corticosteroids are permitted as physiological replacement therapy or as supportive care for nausea and emesis)
- Known history of Human immunodeficiency virus infection
- Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator
- Concurrent serious medical infection or illness, or psychiatric illness likely to interfere with participation in this clinical study.
- History of known hypersensitivity to docetaxel or other drugs formulated with polysorbate 80, bortezomib, boron or mannitol
- Patient has Grade 2 peripheral neuropathy within 14 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase I - Dose Level 1
Carboplatin AUC 5 mg/ml/min (Day 1) Docetaxel 60 mg/m2 (Day 1) Bortezomib 0.7 mg/m2 (Day 1,4,8,11)
|
Dose escalation using traditional Phase I - 3 x 3 design to establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
Other Names:
Establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
Other Names:
Establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
Other Names:
|
Experimental: Phase I - Dose Level 2A
Carboplatin AUC 6 mg/ml/min (Day 1) Docetaxel 60 mg/m2 (Day 1) Bortezomib 0.7 mg/m2 (Day 1,4,8,11)
|
Dose escalation using traditional Phase I - 3 x 3 design to establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
Other Names:
Establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
Other Names:
Establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
Other Names:
|
Experimental: Phase I - Dose Level 2B
Carboplatin AUC 6 mg/ml/min (Day 1) Docetaxel 60 mg/m2 (Day 1) Bortezomib 1.0 mg/m2 (Day 1,4,8,11)
|
Dose escalation using traditional Phase I - 3 x 3 design to establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
Other Names:
Establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
Other Names:
Establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
Other Names:
|
Experimental: Phase I - Dose Level 3
Carboplatin AUC 6 mg/ml/min (Day 1) Docetaxel 60 mg/m2 (Day 1) Bortezomib 1.0 mg/m2 (Day 1,4,8,11)
|
Dose escalation using traditional Phase I - 3 x 3 design to establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
Other Names:
Establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
Other Names:
Establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
Other Names:
|
Experimental: Phase I - Dose Level 4
Carboplatin AUC 6 mg/ml/min (Day 1) Docetaxel 75 mg/m2 (Day 1) Bortezomib 1.0 mg/m2 (Day 1,4,8,11)
|
Dose escalation using traditional Phase I - 3 x 3 design to establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
Other Names:
Establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
Other Names:
Establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
Other Names:
|
Experimental: Phase I - Dose Level 5
Carboplatin AUC 6 mg/ml/min (Day 1) Docetaxel 75 mg/m2 (Day 1) Bortezomib 1.3 mg/m2 (Day 1,4,8,11)
|
Dose escalation using traditional Phase I - 3 x 3 design to establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
Other Names:
Establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
Other Names:
Establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
Other Names:
|
Experimental: Phase II
Carboplatin AUC 5 mg/ml/min (Day 1) Docetaxel 60 mg/m2 (Day 1) Bortezomib 0.7 mg/m2 (Day 1,4,8,11)
|
Dose escalation using traditional Phase I - 3 x 3 design to establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
Other Names:
Establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
Other Names:
Establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine maximum tolerated dose of bortezomib when administered in combination with carboplatin & docetaxel for treatment of patients with advanced NSCLC cancer. Determine the response rate of the combination for patients with advanced NSCLC.
Time Frame: Expected average of 2 years
|
Expected average of 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Define dose-limiting toxicities of the combination of carboplatin, docetaxel & bortezomib for patients with advanced NSCLC. Determine the time to progression & overall survival, assess toxicities, determine changes in serum proteomics patterns
Time Frame: Expected average of 2 years
|
Expected average of 2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chandra P. Belani, MD, Penn State College of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
- Carboplatin
- Bortezomib
Other Study ID Numbers
- PSU 26983
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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