NCT00895362

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 6, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2009

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

July 13, 2015

Status Verified

July 1, 2015

Enrollment Period

6.3 years

First QC Date

May 6, 2009

Last Update Submit

July 10, 2015

Conditions

Advanced Cancers

Keywords

Advanced CancerEGFR mutationErlotinibErlotinib HydrochlorideTarcevaOSI-774CetuximabC225ErbituxIMC-C225

Outcome Measures

Primary Outcomes (2)

  • Maximum Tolerated Dose (MTD) of Erlotinib in Combination with Cetuximab

    MTD defined by dose limiting toxicities (DLTs) that occur in the first cycle. DLT defined as any Grade 3 or 4 non-hematologic toxicity defined in NCI CTC v3.0, even if expected and believed related to study medications (except nausea and vomiting responsive to appropriate regimens or alopecia), any Grade 4 hematologic toxicity lasting 2 weeks or longer (as defined by the NCI-CTCAE), despite supportive care; any Grade 4 nausea or vomiting \> 5 days despite maximum anti-nausea regimens, and any other Grade 3 non-hematologic toxicity, including symptoms/signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complication or abnormality not defined in the NCI-CTCAE that is attributable to therapy.

    28 days

  • Patient Response Rate

    Tumor response defined as one or more of the following: (1) stable disease for more than or equal to 4 months, (2) decrease in measurable tumor (sentinel lesions) by more than or equal to 20% by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, (3) decrease in tumor markers by more than or equal to 25% (for example, a \>/= 25% decrease in cancer antigen 125 (CA125) for patients with ovarian cancer), or (4) a partial response according to the Choi criteria, i.e. decrease in size by 10% or more, or a decrease in tumor density, as measured in Hounsfield units (HU), by more than or equal to 15%.

    After two, 28-day cycles

Study Arms (1)

Erlotinib + Cetuximab

EXPERIMENTAL

Erlotinib in Combination with Cetuximab

Drug: ErlotinibDrug: Cetuximab

Interventions

ErlotinibDRUG

Starting dose 100 mg by mouth 1 time every day for 28-day cycle (Pediatric starting dose 50 mg).

Also known as: Erlotinib Hyrdrochloride, Tarceva, OSI-774
Erlotinib + Cetuximab
CetuximabDRUG

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.

Also known as: C225, Erbitux, IMC-C225
Erlotinib + Cetuximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Measurable or non-measurable disease.
  • Patients must be \>/= 6 wks beyond treatment with a nitrosourea or mitomycin-C, \>/= 4 wks beyond other chemotherapy or external beam radiation therapy (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).
  • (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.
  • Eastern Cooperative Oncology Group (ECOG) performance status \</= 2 (Karnofsky \>/= 60%)
  • Patients must have normal organ and marrow function defined as: absolute neutrophil count \>/=1,000/mL; platelets \>/=50,000/mL; creatinine \</= 2 X upper limit of normal (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.
  • 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.
  • Ability to understand and the willingness to sign a written informed consent document
  • 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 \[PR\]).

You may not qualify if:

  • 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.
  • Uncontrolled systemic vascular hypertension (systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg on medication).
  • Patients with clinically significant cardiovascular disease: history of cardiovascular accident (CVA) within 6 months, myocardial infarction or unstable angina within 6 months, or unstable angina pectoris.
  • Patients with colorectal carcinoma with tumors that demonstrate a Kirsten rat sarcoma (KRAS) mutation.
  • Pregnant or lactating women.
  • Patients with a history of bone marrow transplant within the previous two years.
  • Patients with a known hypersensitivity to any of the components of the drug products.
  • Patients unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with proper absorption of oral drugs.
  • Patients with major surgery within 30 days prior to entering the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

Erlotinib HydrochlorideCetuximab

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jennifer J. Wheler, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2009

First Posted

May 8, 2009

Study Start

April 1, 2009

Primary Completion

July 1, 2015

Last Updated

July 13, 2015

Record last verified: 2015-07

Locations

US(1)