Erlotinib and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Kidney, Colorectal, Head and Neck, Pancreatic, or Non-Small Cell Lung Cancer
A Phase I, and Biologic Correlative Study of Erlotinib, in Combination With Cetuximab and Bevacizumab in Patients With Metastatic Renal Cell Carcinoma
7 other identifiers
interventional
66
1 country
1
Brief Summary
This randomized phase I/II trial studies the side effects, best way to give, and best dose of erlotinib and bevacizumab when given with cetuximab and how well giving erlotinib and cetuximab together with or without bevacizumab works in treating patients with metastatic or unresectable kidney, colorectal, head and neck, pancreatic, or non-small cell lung cancer. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab and 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. Cetuximab and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with cetuximab and/or bevacizumab may kill more tumor cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2005
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 7, 2005
CompletedFirst Posted
Study publicly available on registry
January 10, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedJune 11, 2014
December 1, 2012
2.7 years
January 7, 2005
June 10, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Maximum tolerated dose (MTD) of erlotinib hydrochloride combined with cetuximab determined by dose-limiting toxicities (DLT) graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3 (Part I)
The occurrence and maximal grade of toxicity for the whole duration of treatment will be listed and tabulated by type.
28 days
MTD of bevacizumab combined with cetuximab and erlotinib hydrochloride determined by DLT graded according to the CTCAE version 3 (Part II)
The occurrence and maximal grade of toxicity for the whole duration of treatment will be listed and tabulated by type.
28 days
Secondary Outcomes (3)
Antitumor activity defined as the number and extent (complete or partial) objective responses as well as objective stable disease as measured by RECIST criteria
6 months
Median time to progression
Up to 1 month
Progression-free survival
From the start of the treatment until the date the criteria for progression are met or the date the patient is taken off study for any reason, assessed up to 1 month
Study Arms (1)
Treatment (erlotinib hydrochloride, cetuximab, bevacizumab)
EXPERIMENTALPart 1: Patients receive oral erlotinib once daily on days 1-28. Patients also receive cetuximab IV over 3 hours on day 1 and over 1 hour on days 8, 15, and 22. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Part 2: Patients receive erlotinib as in part 1 at the MTD and cetuximab as in part 1. Patients also receive bevacizumab IV over 1½ hours on day 1 and over 1 hour on day 15. Cohorts of 3-6 patients receive escalating doses of bevacizumab until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. In both groups, courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
Interventions
Given orally
Given IV
Given IV
Correlative studies
Eligibility Criteria
You may qualify if:
- One of the following histologically confirmed diagnoses:
- Renal cell cancer
- Clear cell histology
- Metastatic or unresectable disease AND meets 1 of the following criteria:
- Recurrent disease
- Refractory to interleukin-2 (IL-2)- or interferon-based therapy
- Previously untreated AND not a candidate for IL-2-based therapy
- Colorectal, head and neck, pancreatic, or non-small cell lung cancer
- Metastatic or unresectable disease
- Progression after prior standard treatment
- No evidence of CNS disease, including the following (part 2 only):
- Primary brain tumor
- Brain metastases
- Paraffin embedded tumor blocks available
- Performance status - ECOG 0-2
- +61 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alain Mita
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2005
First Posted
January 10, 2005
Study Start
January 1, 2005
Primary Completion
October 1, 2007
Study Completion
May 1, 2008
Last Updated
June 11, 2014
Record last verified: 2012-12