Study of Combination Therapy of Carboplatin -Gemcitabine Plus Bevacizumab Beyond Progression in Patients With Locally Advanced and/or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Systemic Therapy

NCT00702975 | Completed Phase 2

• 1 other identifier: ULCN0107
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

A phase II study of combination therapy of carboplatin -gemcitabine plus bevacizumab beyond progression in patients with locally advanced and/or metastatic non-small cell lung cancer (NSCLC) who have not received prior chemotherapy.

Conditions

Locally Advanced Non-Small Cell Lung Cancer; NSCLC

Keywords

phase II; NSCLC; bevacizumab; erlotinib; metastatic NSCLC

Outcome Measures

Primary Outcomes (1)

• Efficacy of erlotinib plus bevacizumab subsequent to the combination of carboplatin, paclitaxel and bevacizumab as determined by the maximum achieved disease control rate

  at 18 weeks

Secondary Outcomes (1)

• Efficacy of bevacizumab and erlotinib as determined by DCR; PFS; RR

  at 6, 12 and 27 weeks

Interventions

Paclitaxel, Carboplatin and Bevacizumab,Erlotinib DRUG

4 cycles (or less in case of progression) with carboplatin AUC 6 -paclitaxel 200mg/m2 -bevacizumab 15 mg/kg i.v. At (early) progress Bevacizumab 15 mg/kg i.v. q 21 days plus Erlotinib 150 mg/day orally

Also known as: Carboplatin (L01XA02), Paxene (L01CD01), Avastin(L01XC07), Tarceva(L01XE03)

Eligibility Criteria

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

You may qualify if:

• Advanced stage NSCLC (IIIB with malignant pleural effusion or stage IV excluding squamous cell histology, with measurable or evaluable disease.
• No prior systemic therapy for advanced NSCLC, prior therapy for early stage disease with one regimen is acceptable if it was completed at least 6 months prior to study entry.
• Palliative radiotherapy to painful bony metastases will be permitted prior to study entry if completed prior to initiation of study treatment, and there are no residual sequelae of therapy such as bone marrow suppression.
• Life expectancy of at least 3 months.
• ECOG Performance status 0-1 (see appendix 2)
• Age 18 or higher.
• Female patients with reproductive potential must have a negative serum pregnancy test within 72 hours prior to start of study medication. All female patients of childbearing potential, and all male patients, must agree to use a medically acceptable method of contraception or agree to be abstinent throughout the treatment period and for 3 months after discontinuation of treatment
• Patients must have normal organ and marrow function

You may not qualify if:

• Prior systemic treatment for advanced NSCLC. One prior regimen (up to 4 cycles) of neoadjuvant or adjuvant therapy for early stage disease will be allowed if completed at least 6 months prior to study entry.
• Known brain metastases (in case of clinical signs or symptoms of brain metastases radiological evaluation is mandatory).
• Prior treatment with bevacizumab or erlotinib.
• History of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to bevacizumab or erlotinib.
• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in any other experimental drug study.
• Concomitant chemotherapy, radiotherapy or investigational agents.
• Evidence of bleeding diathesis or coagulopathy.
• Use of full dose anti-coagulant agents.
• Pregnant (positive pregnancy test) or lactating women.
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to start, anticipation of need for major surgical procedure during the course of the study.
• Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to start.
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to start.
• Serious, non-healing wound, ulcer, or bone fracture.
• Lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel, or with significant cavitation as assessed by treating investigator in consultation with an attending radiologist.
• History of hemoptysis (bright red blood of 2.5 ml or more).

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

University Lung Centre Nijmegen Dekkerswald

Groesbeek, Gelderland, 6561 KE, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Paclitaxel; Carboplatin; Bevacizumab; Erlotinib Hydrochloride

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; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• J. Timmer-Bonte, MD, Phd

  UMCN st Radboud

  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: SPONSOR

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: June 20, 2008
• Study Start: September 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 15, 2013

Record last verified: 2012-04

Locations

NL (1)