Docetaxel and Bortezomib in Treating Patients With Progressive or Recurrent Non-Small Cell Lung Cancer

NCT00362882 | Completed Phase 2 Results DMC

• 4 other identifiers: NCI-2009-00123PHII-70N01CM17101CDR0000491470
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is studying two different schedules of docetaxel and bortezomib to compare how well they work in treating patients with progressive or recurrent non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel together with bortezomib may kill more tumor cells

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  Up to 4 years

Secondary Outcomes (3)

• Overall Survival

  From first day of treatment to time of death due to any cause, up to 4 years

• Disease Control Rate

  Up to 4 years

• Progression-free Survival @ 6 Months

  6 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Patients receive docetaxel IV over 60 minutes on day 1 and bortezomib IV over 3-5 seconds on days 1 and 8.

Drug: docetaxel; Drug: bortezomib; Other: laboratory biomarker analysis; Other: immunoenzyme technique; Other: immunohistochemistry staining method; Other: pharmacological study

Arm 2

EXPERIMENTAL

Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 2 and 8.

Drug: docetaxel; Drug: bortezomib; Other: laboratory biomarker analysis; Other: immunoenzyme technique; Other: immunohistochemistry staining method; Other: pharmacological study

Interventions

docetaxel DRUG

Given IV

Also known as: RP 56976, Taxotere, TXT

Arm 1; Arm 2

bortezomib DRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE

Arm 1; Arm 2

laboratory biomarker analysis OTHER

correlative study

Arm 1; Arm 2

immunoenzyme technique OTHER

correlative study

Also known as: immunoenzyme techniques

Arm 1; Arm 2

immunohistochemistry staining method OTHER

correlative study

Also known as: immunohistochemistry

Arm 1; Arm 2

pharmacological study OTHER

correlative study

Also known as: pharmacological studies

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Criteria: * No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer for which the patient is currently in complete remission, or any other cancer for which the patient has been disease-free for 5 years. * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). * Progressive or recurrent NSCLC after treatment with 1 prior platinum-based chemotherapy regimen for metastatic disease. Prior neoadjuvant/adjuvant chemotherapy and/or concurrent chemoradiation for early-stage disease allowed. * At least 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas) and recovered. * No prior docetaxel or bortezomib * Prior epidermal growth factor receptor inhibitor therapy allowed. * Prior paclitaxel allowed * At least 4 weeks since prior major surgery and recovered. * At least 2 weeks since prior and no concurrent enzyme-inducing anticonvulsants. * No concurrent hormonal therapy, biologic therapy, or radiotherapy to measurable lesions. Concurrent palliative radiotherapy to small-field nonindicator lesions (e.g., painful bony metastases) allowed. * Measurable disease\* with \>= 1 unidimensionally objectively measurable lesion, including any of the following: * Lung mass (measurable on chest x-ray, tomograms, or CT scan) * Enlarged lymph nodes * Liver metastasis (measurable as a discrete focal lesion on radionuclide or CT scan, or ultrasound) * Metastatic abdominal mass (measurable on CT scan with \>= 1 perpendicular diameter ≥ the distance between cuts) * Measurable disease must be outside the previous radiation field or a new lesion must be present. * Life expectancy \>= 12 weeks * Progressive disease within a previously radiated field allowed. * \[Note: \*Measurable disease DOES NOT include bone metastases or non-focal liver metastases\]. * No symptomatic or untreated brain metastasis requiring steroids. Asymptomatic, previously treated (surgical resection or radiotherapy) brain metastasis allowed provided they are neurologically stable and \>= 4 weeks since prior steroids. * Creatinine clearance \>= 50 mL/min * Creatinine =\< 1.6 mg/dL * Bilirubin normal * AST =\< 2 times upper limit of normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No peripheral neuropathy \>= grade 2 * Absolute granulocyte count \>= 1,500/mm³ * Platelet count \>= 100,000/mm³ * Cutaneous nodule * ECOG performance status 0-1 * At least 4 weeks since prior radiotherapy and recovered.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; Bortezomib; Immunoenzyme Techniques; Immunohistochemistry

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)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Immunoassay; Immunologic Techniques; Investigative Techniques; Molecular Probe Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques

Results Point of Contact

• Title: DCC Project Administrator
• Organization: California Cancer Consortium

CCCP@coh.org

626-256-4673

Study Officials

• Primo Lara

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 10, 2006
• First Posted: August 15, 2006
• Study Start: July 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 5, 2017
• Results First Posted: October 2, 2014

Record last verified: 2017-10

Locations

US (1)