Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043823
Status:
COMPLETED
Last Update Posted:
2018-11-07
First Post:
2002-08-14
Brief Title:
Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Safety and Efficacy of Recombinant Humanized Monoclonal Anti-VEGF Antibody rhuMAb VEGF and EGFR Tyrosine Kinase Inhibitor OSI-774 for Locally Advanced or Metastatic Non-Squamous Cell NSCLC in Patients Who Have Been Previously Treated
Status:
COMPLETED
Status Verified Date:
2018-11
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:
Primary Objectives
1 Phase I To establish the maximum tolerated dose and dose-limiting toxicities of the combination of OSI-774 Tarceva and rhuMAb VEGF Avastin in patients with advanced Non-small-cell lung carcinoma NSCLC
2 Phase II To assess response rate and tolerability of the regimen at the dose level established in the phase I portion of this study
Secondary Objectives
1 Phase I and II To evaluate the pharmacokinetic interaction between the combination
2 Phase I To establish a phase II regimen of the OSI-774 rhuMAb VEGF combination for further study alone or in combination with cytotoxic chemotherapy
1 Phase I To establish the maximum tolerated dose and dose-limiting toxicities of the combination of OSI-774 Tarceva and rhuMAb VEGF Avastin in patients with advanced Non-small-cell lung carcinoma NSCLC
2 Phase II To assess response rate and tolerability of the regimen at the dose level established in the phase I portion of this study
Secondary Objectives
1 Phase I and II To evaluate the pharmacokinetic interaction between the combination
2 Phase I To establish a phase II regimen of the OSI-774 rhuMAb VEGF combination for further study alone or in combination with cytotoxic chemotherapy
Detailed Description:
Patients will be treated with oral Tarceva daily for 21 days each cycle Patients will receive Avastin by IV on day 1 of each 21-day cycle If a patient has no grade 3 or 4 toxicities after the 1st cycle then the patient may continue the same doses of Tarceva and Avastin for another cycle If the patient has response or stable disease after 6 weeks 2 cycles the patient may continue on the same doses of Tarceva and Avastin A patient may receive treatment on this study for up to one year unless his or her disease progresses or side effects become too severe
The starting dose is 100 mg daily of Tarceva and 75 mgkg every 21 days of Avastin
The starting dose is 100 mg daily of Tarceva and 75 mgkg every 21 days of Avastin
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 |
|---|---|---|---|
| VICC THO 0206 | None | None | None |