Bortezomib in Combination With Gemcitabine and Cisplatin in Advanced or Metastatic Non-Small Cell Lung Cancer

NCT01633645 | Completed Phase 2

• 1 other identifier: 26866138-LUC-2006
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 5

Brief Summary

The primary objective of this study is to establish the objective response rate (complete response + partial response) following treatment with VELCADE in combination with cisplatin plus gemcitabine in patients with locally advanced (Stage IIIb) or metastatic (stage IV non-small cell lung cancer (NSCLC) who have not received prior antineoplastic therapy for advanced disease

Conditions

Non Small Cell Lung Cancer; Metastatic

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Participants will be evaluated for response to the study treatment after the first three treatment cycles (cycle repeated every 21 days) and then every two treatment cycles (completion of cycles 5, 7, 9 etc.) until documentation of disease progression.

  Up to 9 weeks

Secondary Outcomes (3)

• Progression free survival

  1 year

• Overall survival

  1 year

• Number of participants with adverse events

  Participants will be followed for adverse events up to 24 weeks

Study Arms (1)

Velcade/GEM/CDDP

EXPERIMENTAL

Bortezomib / Gemcitabine / Cisplatin

Drug: Bortezomib; Drug: Gemcitabine; Drug: Cisplatin

Interventions

Bortezomib DRUG

Velcade

Also known as: VELCADE 1 mg/m2 on days 1 and 8, of a 21-days treatment cycle for a maximum of 8 cycles

Velcade/GEM/CDDP

Gemcitabine DRUG

Gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-days treatment cycle for a maximum of 8 cycles

Also known as: Gemzar

Velcade/GEM/CDDP

Cisplatin DRUG

Cisplatin 70 mg/m2 on day 1 of a 21-days treatment cycle for a maximum of 8 cycles

Also known as: CDDP

Velcade/GEM/CDDP

Eligibility Criteria

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

You may qualify if:

• Men or women, 18 years of age or older.
• NSCLC histologically or cytologically confirmed.
• Locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC.
• No prior systemic anti-neoplastic therapy for Stage IIIB/IV NSCLC (one prior line is allowed if given as adjuvant or neo-adjuvant therapy).
• Measurable disease per RECIST criteria.
• ECOG performance status score of 0 - 1.
• Life expectancy greater than 3 months.
• Female patients must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and have a negative serum or urine β-human chorionic gonadotropin (hCG) pregnancy test at screening.
• Patients (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to and able to comply with the protocol requirements and participate in the study before any study-related procedure not part of normal medical care is conducted.
• Patients (or their legally acceptable representatives) must have signed an informed consent for testing indicating, that they agree to participate in the correlative marker part of the study.

You may not qualify if:

• Peripheral neuropathy of Grade 2 or greater intensity, as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE Version 3.0).
• Previous treatment with VELCADE.
• Prior systemic anti-neoplastic therapies for Stage IIIB/IV NSCLC except if as neoadjuvant therapy for Stage IIIB.
• Any prior systemic anti-neoplastic therapy for NSCLC (i.e., prior chemotherapy, radiation therapy, prior monoclonal antibodies or any investigational drug or any major surgery) within 4 weeks before enrollment.
• Significant weight loss (documented \< 10% body weight in the 6 weeks before enrollment).
• Inadequate organ function at the screening visit as defined by the following laboratory values:
• Platelet count ≤ 100 x 109/L
• Hemoglobin ≤ 8.0 g/dL (80 g/L)
• Absolute neutrophil count (ANC) ≤ 1.5 x 109/L
• AST ≥ 3 times the upper limit of the normal range (upper normal limit) or \> 5 times the upper normal limit for subjects with liver metastases
• ALT ≥ 3 times ULN or \> 5 times the upper normal limit for subjects with liver metastases (Calculated creatinine clearance ≥ 45 mL/min, Total bilirubin ≥ 1.5 times Upper normal limit)
• Myocardial infarction within 6 months before randomization or has New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
• Central nervous system metastasis or brain metastases unless patients have been subjected to local radiation therapy and are clinically stable. Brain computed tomography or magnetic resonance imaging is required in symptomatic patients to rule out brain metastases but is not required in asymptomatic patients.
• Serious medical condition (such as severe hepatic impairment, pericardial disease, acute diffuse infiltrative pulmonary disease, systemic infections etc) or psychiatric illness likely to interfere with participation in this study
• Other malignancy within the past 5 years. Exceptions for the following if treated and not active: basal cell or non-metastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or International Federation of Gynecology and Obstetrics Stage 1 carcinoma of the cervix.

Sponsors & Collaborators

• University Hospital of Crete: lead

Study Sites (5)

Air Forces Military Hospital of Athens Athens, Greece

Athens, Greece

Location

METAXA Hospital, B' Pathology Department

Athens, Greece

Location

SOTIRIA Hospital, Medical Oncology Department

Athens, Greece

Location

University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece

Heraklion, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Interventions

Bortezomib; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Vassilis Georgoulias, MD

  University Hospital of Heraklion

  PRINCIPAL INVESTIGATOR

• Sofia Aggelaki, MD

  University Hospital of Heraklion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. V.Georgoulias

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: July 4, 2012
• Study Start: June 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: September 28, 2015

Record last verified: 2015-09

Locations

GR (5)