NCT00459901

Brief Summary

To document the antitumor activity of capecitabine in combination with erlotinib in patients with previously untreated metastatic colorectal cancer. Time to tumor progression, objective response rate, time to confirmed response rate, duration of confirmed response rate, time to treatment failure, and CEA response will be assessed.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2007

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

1 year

First QC Date

April 11, 2007

Last Update Submit

April 28, 2015

Conditions

Metastatic Colorectal Cancer

Keywords

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • To document the antitumor activity of capecitabine in combination with erlotinib in patients with previously untreated metastatic colorectal cancer

    Time to tumor progression, time to confirmed response rate, time to treatment failure, .

Secondary Outcomes (1)

  • To determine the qualitative and quantitative toxicity of this combination and sequence of drug administration

    Objective response rate, duration of confirmed response rate, CEA response will be assessed.

Interventions

Erlotinib and capecitabineDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients who have histologically or cytologically confirmed diagnosis of metastatic colorectal adenocarcinoma.
  • Patients must be \> 18 years old.
  • Patients must have a performance status of \> 60 on the Karnofsky scale
  • Patients must have an expected life expectancy of at least 12 weeks.
  • Patients must give written informed consent as per institutional and federal regulatory requirements.
  • Patients must have measurable or evaluable disease .
  • Patients must have an absolute neutrophil count of \> 1,500/mm3 and a platelet count \> 100,000/mm3.
  • Patients must have adequate liver and renal function defined by a bilirubin of \< 2.0 mg/dl and a creatinine of \< 1.5 mg/dl, respectively.
  • Patients must be able to stay in the general area for the duration of their treatment on this clinical research study.

You may not qualify if:

  • Prior chemotherapy, treatment with inhibitors of EGFR of any kind, molecularly targeted
  • Pregnant or lactating women
  • Clinical signs of brain involvement or leptomeningeal disease
  • Serious illness or medical conditions
  • Congestive heart failure or unstable angina pectoris, uncontrolled hypertension or arrhythmias
  • Active infections
  • UnstaOphthalmic disorders that might increase the risk for epithelium related complications (bullous keratopathy, aniridia, severe chemical burns, neutrophilic keratitis e.g.)
  • GI tract disease resulting in an inability to take oral medication such as uncontrolled inflammatory GI disease (e.g. Crohn's disease, ulcerative colitis) or post surgical malabsorption characterized by uncontrolled diarrhea that results in weight loss and vitamin deficiency orequires IV hyperalimentation (however, use of pancreatic enzyme supplementation is allowed provided that the above criteria are not met).
  • Prior invasive malignancies for less 5 years
  • Known to be HIV positive.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Related Publications (1)

  • Van Halteren HK, Roumen RM, Coebergh JW, Croiset van Uchelen FA, Keuning JJ, Vreugdenhil G. The impact of 5-FU-based bolus chemotherapy on survival in patients with advanced colorectal cancer. Anticancer Res. 1999 Jul-Aug;19(4C):3447-9.

    PMID: 10629633BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Erlotinib HydrochlorideCapecitabine

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Peter Kozuch, MD

    Continuum Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending

Study Record Dates

First Submitted

April 11, 2007

First Posted

April 13, 2007

Study Start

June 1, 2004

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

April 29, 2015

Record last verified: 2015-04

Locations

US(1)