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

Completed · Phase 2

Conditions studied: Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

In brief

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

Key facts

Study ID: NCT00075751
Run by: National Cancer Institute (NCI)
People needed: 99
Starts: 2004-01-01
Last updated by the study team: 2013-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
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

Where it is running

Southwest Oncology Group — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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