Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

NCT00052338 | Completed Phase 1

• 4 other identifiers: NCI-2012-02503PHI-40N01CM17101CDR0000258189
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and bortezomib may kill more tumor cells

Conditions

Malignant Pleural Effusion; 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)

• Toxicities at each dose level, graded using the CTC version 2.0

  Summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity, (by NCI Common Toxicity Criteria and nadir or maximum values for the laboratory measures, time of onset (i.e. course number), duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and course.

  18 weeks

Secondary Outcomes (3)

• Response rate, assessed by standard RECIST criteria

  Up to 2 years

• Survival

  From registration to time of death due to any cause, assessed up to 2 years

• Time to failure

  Up to 2 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, followed 1 hour later by 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 a clinical or radiographic response may continue receiving bortezomib beyond 6 courses.

Drug: gemcitabine hydrochloride; Drug: carboplatin; Drug: bortezomib; Other: laboratory biomarker analysis

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)

laboratory biomarker analysis OTHER

Correlative studies

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:

• Histologically or cytologically confirmed non-small cell lung cancer
• Selected stage IIIB (malignant pleural effusion) or stage IV disease
• Recurrent disease after first-line therapy allowed
• Patients who received prior platinum-based chemotherapy must have no disease progression during or within 3 months after completion of therapy
• Patients who are enrolled at the maximum tolerated dose must have chemotherapy-naïve disease
• Evaluable disease
• Asymptomatic brain metastases allowed if treated with surgical resection or radiotherapy, neurologically stable, and off steroids for at least 4 weeks
• Performance status - Karnofsky 60-100%
• More than 3 months
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Bilirubin no greater than 1.5 mg/dL
• AST no greater than 2.5 times upper limit of normal
• Creatinine normal
• Creatinine clearance at least 50 mL/min

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

City of Hope

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Pleural Effusion, Malignant; Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine; Carboplatin; Bortezomib

Condition Hierarchy (Ancestors)

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

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2003
• First Posted: January 27, 2003
• Study Start: September 1, 2002
• Primary Completion: May 1, 2004
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

US (1)