Erlotinib and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic or Unres… (NCT00101348) | Clinical Trial Compass
CompletedPhase 1/2
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
United States66 participantsStarted 2005-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* Performance status - Karnofsky 60-100%
* More than 12 weeks
* Absolute neutrophil count ≥ 1,500 mm\^3
* Platelet count ≥ 100,000 mm\^3
* Bilirubin ≤ 1.5 mg/dL
* AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastasis is present)
* PTT and INR ≤ 1.5, unless receiving full-dose warfarin (part 2 only)
* Creatinine ≤ 1.5 times ULN
* Creatinine clearance ≥ 60 mL/min
* Calcium \< 10 mg/dL (hypocalcemic agents allowed)
* No proteinuria\*
* Protein \< 1 g on 24-hour urine collection\*
* No unstable angina pectoris
* No cardiac arrhythmia
* No symptomatic congestive heart failure
* None of the following are allowed for part 2:
* Myocardial infarction within the past 6 months
* New York Heart Association class II-IV heart diseas…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
Timeframe: 28 days
2
MTD of bevacizumab combined with cetuximab and erlotinib hydrochloride determined by DLT graded according to the CTCAE version 3 (Part II)