Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354549
Status:
COMPLETED
Last Update Posted:
2019-05-15
First Post:
2006-07-19
Brief Title:
Bevacizumab and Erlotinib Followed by Cisplatin or Carboplatin and Gemcitabine in Treating Patients With Newly Diagnosed or Recurrent Stage IIIB or Stage IV NSCLC
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Bevacizumab and Erlotinib First-Line Therapy in Advanced Non-Squamous Non-Small-Cell Lung Cancer Stage IIIBIV Followed by Platinum-Based Chemotherapy at Disease Progression A Multicenter Phase II Trial
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as cisplatin carboplatin and gemcitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving bevacizumab together with erlotinib followed by cisplatin or carboplatin and gemcitabine at disease progression may be an effective treatment for non-small cell lung cancer
PURPOSE This phase II trial is studying how well giving bevacizumab together with erlotinib followed by cisplatin or carboplatin and gemcitabine works in treating patients with newly diagnosed or recurrent stage IIIB or stage IV non-small cell lung cancer
PURPOSE This phase II trial is studying how well giving bevacizumab together with erlotinib followed by cisplatin or carboplatin and gemcitabine works in treating patients with newly diagnosed or recurrent stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Assess the efficacy of bevacizumab and erlotinib hydrochloride as initial therapy in patients with newly diagnosed or recurrent stage IIIB or IV non-squamous non-small cell lung cancer NSCLC
Secondary
Assess the safety of bevacizumab and erlotinib hydrochloride as initial therapy in these patients
Assess the quality of life QOL in patients treated with bevacizumab and erlotinib hydrochloride
Assess the efficacy and safety of subsequent cisplatin or carboplatin in combination with gemcitabine hydrochloride in patients who have disease progression
Assess the QOL in patients treated with subsequent cisplatin or carboplatin in combination with gemcitabine hydrochloride at disease progression
Tertiary
Identify novel biomarkers in predicting response to therapy and toxicity in patients treated with bevacizumab and erlotinib hydrochloride as initial therapy
OUTLINE This is a multicenter prospective open-label study
Patients receive bevacizumab IV over 90 minutes on day 1 and oral erlotinib hydrochloride once daily on days 1-21 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Beginning within 3 weeks of documented disease progression patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 They also receive cisplatin IV over 1 hour or carboplatin IV over 30 minutes on day 1 Treatment with gemcitabine hydrochloride with either cisplatin or carboplatin repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and periodically during study treatment
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 101 patients will be accrued for this study
Primary
Assess the efficacy of bevacizumab and erlotinib hydrochloride as initial therapy in patients with newly diagnosed or recurrent stage IIIB or IV non-squamous non-small cell lung cancer NSCLC
Secondary
Assess the safety of bevacizumab and erlotinib hydrochloride as initial therapy in these patients
Assess the quality of life QOL in patients treated with bevacizumab and erlotinib hydrochloride
Assess the efficacy and safety of subsequent cisplatin or carboplatin in combination with gemcitabine hydrochloride in patients who have disease progression
Assess the QOL in patients treated with subsequent cisplatin or carboplatin in combination with gemcitabine hydrochloride at disease progression
Tertiary
Identify novel biomarkers in predicting response to therapy and toxicity in patients treated with bevacizumab and erlotinib hydrochloride as initial therapy
OUTLINE This is a multicenter prospective open-label study
Patients receive bevacizumab IV over 90 minutes on day 1 and oral erlotinib hydrochloride once daily on days 1-21 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Beginning within 3 weeks of documented disease progression patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 They also receive cisplatin IV over 1 hour or carboplatin IV over 30 minutes on day 1 Treatment with gemcitabine hydrochloride with either cisplatin or carboplatin repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and periodically during study treatment
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 101 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20614 | None | None | None |