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Recurrent Non-small Cell Lung CancerPhase 2NCT00075751

Gemcitabine, Carboplatin, and Bortezomib in Advanced or Recurrent Non-Small Cell Lung Cancer

A Phase 2 study testing gemcitabine hydrochloride, carboplatin and bortezomib in people with Recurrent Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase II trial to study the effectiveness of combining bortezomib with gemcitabine and carboplatin in treating patients who have advanced or recurrent non-small cell lung cancer that has not been previously treated with chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
gemcitabine hydrochloride, carboplatin and bortezomib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 siteUnited States
Study dates
Jan 2004to Jul 2007
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically proven selected stage IIIB (T4 lesion due to malignant pleural effusion) or stage IV, advanced non-small cell lung cancer or recurrent disease after previous surgery and/or radiation
  • Patients with known brain metastases are not eligible for this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; all patients must have a pretreatment CT or MRI scan of the brain to evaluate for CNS disease within 28 days prior to registration
  • Patients must have measurable OR non-measurable disease documented by CT, MRI, or x-ray; measurable disease must be assessed within 28 days prior to registration and non-measurable disease must be assessed within 42 days prior to registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease
  • Patients must not have received any prior systemic chemotherapy or biological agent for non-small cell lung cancer; prior radiation is permitted; however, two weeks must have elapsed since the completion of prior radiation therapy and patients must have recovered from all associated toxicities at the time of registration; measurable or non-measurable disease must be outside the previous radiation field or a new lesion inside the port must be present
  • At least two weeks must have elapsed since surgery (thoracic or other major surgeries) and patients must have recovered from all associated toxicities at the time of registration
  • Serum creatinine =< the institutional upper limit of normal OR a creatinine clearance >= 60 cc/min; these tests must have been performed within 28 days prior to registration
Show all 20Show fewer
  • ANC >= 1500/ul obtained within 14 days prior to registration
  • Platelet count >= 100,000/ul obtained within 14 days prior to registration
  • Serum bilirubin =< institutional upper limit of normal obtained within 28 days prior to registration
  • SGOT or SGPT =< 2.5 x the institutional upper limit of normal obtained within 28 days prior to registration
  • All patients must have a Zubrod performance status of 0-1
  • Peripheral neuropathy, if present, must be =< grade 1 (NCI Common Terminology Criteria for Adverse Events version 3.0)
  • Correlative science studies: Institutions must have IRB approval of S9925 (the Lung Cancer Specimen Repository); patients must be offered participation in S9925; with the patient's consent, tumor tissue, blood and plasma will be submitted for testing via S9925; patients must be registered separately to S9925 in order for institutions to receive credit for specimen submissions
  • Patients known to be HIV positive and receiving anti-retroviral therapy (HAART) are not eligible for this study because of possible pharmacokinetic interactions
  • Patients must not be planning to receive any other concomitant anticancer treatment including chemotherapy, radiation therapy, biologic agents or any other investigational drugs
  • Patients should not have known hypersensitivity to boron, mannitol, or PS-341; if day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day; in calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday four weeks later would be considered day 28; this allows for efficient patient scheduling without exceeding the guidelines
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 5 years
  • Pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including fetal death from the chemotherapeutic agents; women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Southwest Oncology Group

    San Antonio, Texas, 78245

Other trials in United States

About this study

Official title: A Phase II Trial of Gemcitabine, Carboplatin and PS-341 (NSC-681239) in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

Phase II trial to study the effectiveness of combining bortezomib with gemcitabine and carboplatin in treating patients who have advanced or recurrent non-small cell lung cancer that has not been previously treated with chemotherapy. Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Bortezomib may also help gemcitabine and carboplatin kill more tumor cells by making the cells more sensitive to the drugs

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess overall survival in chemo-naϊve patients with advanced non-small cell lung cancer (NSCLC) treated with combination of gemcitabine, carboplatin and PS-341.

SECONDARY OBJECTIVES:

  1. To assess response rate (confirmed plus unconfirmed, complete plus partial), in the subset of patients with measurable disease, progression-free survival and quantitative toxicities in this group of patients treated with this regimen.

II. To investigate in an exploratory manner, the association of levels of hypoxia-induced secreted proteins and tumor DNA in plasma levels of apoptosis-associated proteins in tumor tissue, and the changes in the levels of PS-341 modulated proteins in peripheral white blood cells with patient response and survival.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes on days 1 and 8, carboplatin IV over 15-30 minutes on day 1, and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue to receive bortezomib alone on the above schedule for up to 1 year at the discretion of the treating physician.

Patients are followed every 6 months for up to 3 years after registration.

PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study within 5 months.

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.

  • gemcitabine hydrochlorideDrug

    Also called dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

    Given IV

  • carboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Given IV

  • bortezomibDrug

    Also called LDP 341, MLN341, VELCADE

    Given IV

Study groups in NCT00075751
Study groupRoleWhat they receive
Treatment (gemcitabine hydrochloride, carboplatin, bortezomib)ExperimentalPatients receive gemcitabine IV over 30 minutes on days 1 and 8, carboplatin IV over 15-30 minutes on day 1, and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue to receive bortezomib alone on the above schedule for up to 1 year at the discretion of the treating physician.
Receives: Drug: gemcitabine hydrochloride; Drug: carboplatin; Drug: bortezomib

What is being measured

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

  1. Overall survival

    Measured: Up to 3 years

Secondary outcomes (3)

  1. Response rate (confirmed plus unconfirmed, complete plus partial)

    Measured: Up to 12 weeks

  2. Progression-free survival

    Measured: Up to 3 years

  3. Toxicities, based on the National Cancer Institute Common Toxicity Criteria (NCI CTC) v3.0

    Measured: Up to 3 years

Timeline

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

  1. First posted13 Jan 2004 (estimated)
  2. Study startJan 2004
  3. Primary completionJul 2007

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00075751
Sponsor's protocol ID
NCI-2012-03183
Other IDs
S0339, U10CA032102, CDR0000349336
Status last verified
Feb 2013
First submitted
9 Jan 2004
Last updated
28 Feb 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine hydrochloride, carboplatin and bortezomib in people with Recurrent Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) 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 20 inclusion and 0 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: finished, as of the sponsor's last update on 28 Feb 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall survival (time frame: Up to 3 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 NCT00075751.

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 28 Feb 2013.

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