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

NCT00075751 | Completed Phase 2

• 4 other identifiers: NCI-2012-03183S0339U10CA032102CDR0000349336
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Up to 3 years

Secondary Outcomes (3)

• Response rate (confirmed plus unconfirmed, complete plus partial)

  Up to 12 weeks

• Progression-free survival

  Up to 3 years

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

  Up to 3 years

Study Arms (1)

Treatment (gemcitabine hydrochloride, carboplatin, bortezomib)

EXPERIMENTAL

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.

Drug: gemcitabine hydrochloride; Drug: carboplatin; Drug: bortezomib

Interventions

gemcitabine hydrochloride DRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

Treatment (gemcitabine hydrochloride, carboplatin, bortezomib)

carboplatin DRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin

Treatment (gemcitabine hydrochloride, carboplatin, bortezomib)

bortezomib DRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE

Treatment (gemcitabine hydrochloride, carboplatin, bortezomib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Southwest Oncology Group

San Antonio, Texas, 78245, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine; Carboplatin; Bortezomib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines

Study Officials

• Angela Davies

  SWOG Cancer Research Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2004
• First Posted: January 13, 2004
• Study Start: January 1, 2004
• Primary Completion: July 1, 2007
• Last Updated: February 28, 2013

Record last verified: 2013-02

Locations

US (1)