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Non Small Cell Lung CancerPhase 1NCT00714246

Bortezomib (PS-341) in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer

A Phase 1 study testing Bortezomib, Carboplatin and Docetaxel in people with Non Small Cell Lung Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a phase I/II study. The phase I portion of the study will determine the maximum tolerated dose of bortezomib when administered in combination with carboplatin \& docetaxel and to determine the efficacy of the combination for patients with advanced NSCLC. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Bortezomib, Carboplatin and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
Oct 2008to May 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • Adequate bone marrow function
  • Adequate renal function
  • Adequate hepatic function

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: Phase I/II Study of Bortezomib (PS-341) in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer

This is a phase I/II study. The phase I portion of the study will determine the maximum tolerated dose of bortezomib when administered in combination with carboplatin \& docetaxel and to determine the efficacy of the combination for patients with advanced NSCLC. Phase II will utilize the dosage determined in the Phase I and implement regimen to determine time to progression, overall survival, and changes in serum proteomics patterns before \& after combination therapy.

Read the 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.

Keywords
advanced non small cell lung cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BortezomibDrug

    Also called VELCADE, PS-341

    Dose escalation using traditional Phase I - 3 x 3 design to establish MTD of bortezomib when administered in combination with carboplatin and docetaxel

  • CarboplatinDrug

    Also called Paraplatin

    Establish MTD of bortezomib when administered in combination with carboplatin and docetaxel

  • DocetaxelDrug

    Also called Taxotere

    Establish MTD of bortezomib when administered in combination with carboplatin and docetaxel

Study groups in NCT00714246
Study groupRoleWhat they receive
Phase I - Dose Level 1ExperimentalCarboplatin AUC 5 mg/ml/min (Day 1) Docetaxel 60 mg/m2 (Day 1) Bortezomib 0.7 mg/m2 (Day 1,4,8,11)
Receives: Drug: Bortezomib; Drug: Carboplatin; Drug: Docetaxel
Phase I - Dose Level 2AExperimentalCarboplatin AUC 6 mg/ml/min (Day 1) Docetaxel 60 mg/m2 (Day 1) Bortezomib 0.7 mg/m2 (Day 1,4,8,11)
Receives: Drug: Bortezomib; Drug: Carboplatin; Drug: Docetaxel
Phase I - Dose Level 2BExperimentalCarboplatin AUC 6 mg/ml/min (Day 1) Docetaxel 60 mg/m2 (Day 1) Bortezomib 1.0 mg/m2 (Day 1,4,8,11)
Receives: Drug: Bortezomib; Drug: Carboplatin; Drug: Docetaxel
Phase I - Dose Level 3ExperimentalCarboplatin AUC 6 mg/ml/min (Day 1) Docetaxel 60 mg/m2 (Day 1) Bortezomib 1.0 mg/m2 (Day 1,4,8,11)
Receives: Drug: Bortezomib; Drug: Carboplatin; Drug: Docetaxel
Phase I - Dose Level 4ExperimentalCarboplatin AUC 6 mg/ml/min (Day 1) Docetaxel 75 mg/m2 (Day 1) Bortezomib 1.0 mg/m2 (Day 1,4,8,11)
Receives: Drug: Bortezomib; Drug: Carboplatin; Drug: Docetaxel
Phase I - Dose Level 5ExperimentalCarboplatin AUC 6 mg/ml/min (Day 1) Docetaxel 75 mg/m2 (Day 1) Bortezomib 1.3 mg/m2 (Day 1,4,8,11)
Receives: Drug: Bortezomib; Drug: Carboplatin; Drug: Docetaxel
Phase IIExperimentalCarboplatin AUC 5 mg/ml/min (Day 1) Docetaxel 60 mg/m2 (Day 1) Bortezomib 0.7 mg/m2 (Day 1,4,8,11)
Receives: Drug: Bortezomib; Drug: Carboplatin; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Expected average of 2 years

Secondary outcomes (1)

  1. 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

    Measured: Expected average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionMay 2013
  4. Study completionMay 2013

Why it stopped: Low accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00714246
Sponsor's protocol ID
PSU 26983
Status last verified
Jun 2019
First submitted
7 Jul 2008
Last updated
24 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bortezomib, Carboplatin and Docetaxel in people with Non Small Cell Lung Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Low accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00714246.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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