Erlotinib in Combination With Cetuximab

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00895362
First received: May 6, 2009
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

The goal of this clinical research study is to find the highest tolerable dose of Tarceva (erlotinib hydrochloride) that can safely be given in combination with Erbitux (cetuximab). The safety of this drug combination will also be studied.


Condition Intervention Phase
Advanced Cancers
Drug: Erlotinib
Drug: Cetuximab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose-Escalation Study of Erlotinib in Combination With Cetuximab in Subjects With Advanced Cancer. Companion Study to Umbrella Protocol 2007-0638.

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: With each 28 day cycle ] [ Designated as safety issue: Yes ]
    Continuous assessment of safety throughout entire study period and determination of MTD by dose-limiting toxicities during and at the end of 28 day cycle.

  • Patient Response Rate [ Time Frame: Response evaluation every two 28-day cycles ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: April 2009
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib + Cetuximab
Erlotinib in Combination with Cetuximab
Drug: Erlotinib
Starting dose 100 mg by mouth 1 time every day for 28-day cycle (Pediatric starting dose 50 mg).
Other Names:
  • Erlotinib
  • Erlotinib Hyrdrochloride
  • Tarceva
  • OSI-774
Drug: Cetuximab
Loading dose of 200 mg/m^2 (maintenance 125 mg/m^2) by vein 1 day every week of 28-day cycle, on Days 1, 8, 15 and 22. First dose given over 2 hours and over 1 hour each subsequent time.
Other Names:
  • C225
  • Erbitux
  • IMC-C225

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with pathologically confirmed advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have had no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months.
  2. Measurable or non-measurable disease.
  3. Patients must be >/= 6 wks beyond treatment with a nitrosourea or mitomycin-C, >/= 4 wks beyond other chemotherapy or XRT, and must have recovered to </= Grade 1 toxicity for any treatment-limiting toxicity resulting from prior therapy. (Exception: patients may have received palliative low dose XRT one week before treatment provided it is not given to the only targeted lesions).
  4. (continued from above) Also, patients who have received non-chemotherapeutic biological agents will need to wait at least 5 half-lives or 4 wks, whichever is shorter, from the last day of treatment.
  5. ECOG performance status </= 2 (Karnofsky >/= 60%)
  6. Patients must have normal organ and marrow function defined as: absolute neutrophil count >/=1,000/mL; platelets >/=50,000/mL; creatinine </= 2 X ULN; total bilirubin </= 2.0; ALT(SGPT) </= 3 X ULN; Exception for patients with liver metastasis: total bilirubin </= 3 x ULN; ALT(SGPT) </= 5 X ULN.
  7. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose.
  8. Ability to understand and the willingness to sign a written informed consent document
  9. For the MTD expansion cohort, patients will be eligible if they meet one of the following criteria: (I) Have an EGFR-sensitive mutation and have been previously treated with EGFR inhibitor therapy but have subsequently developed resistance, OR (II) Have an EGFR-resistant mutation, OR (III) Do not have an EGFR mutation, but have benefited from EGFR inhibitor therapy (including either >/=4 months of stable disease [SD] OR a >/= partial response [PR]).

Exclusion Criteria:

  1. Patients with uncontrolled concurrent illness, including but not limited to: ongoing or active infection; altered mental status or psychiatric illness/social situations that would limit compliance with study requirements and/or obscure study results.
  2. Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg on medication).
  3. Patients with clinically significant cardiovascular disease: history of CVA within 6 months, myocardial infarction or unstable angina within 6 months, or unstable angina pectoris.
  4. Patients with colorectal carcinoma with tumors that demonstrate a KRAS mutation.
  5. Pregnant or lactating women.
  6. Patients with a history of bone marrow transplant within the previous two years.
  7. Patients with a known hypersensitivity to any of the components of the drug products.
  8. Patients unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with proper absorption of oral drugs.
  9. Patients with major surgery within 30 days prior to entering the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895362

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Jennifer J. Wheler, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00895362     History of Changes
Other Study ID Numbers: 2008-0553
Study First Received: May 6, 2009
Last Updated: July 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
EGFR mutation
Erlotinib
Erlotinib Hydrochloride
Tarceva
OSI-774
Cetuximab
C225
Erbitux
IMC-C225

Additional relevant MeSH terms:
Neoplasms
Cetuximab
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014