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Study of the Antitumor Activity of Capecitabine in Combination With Erlotinib in Patients With Metastatic Colorectal Cancer

Primary Purpose

Metastatic Colorectal Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Erlotinib and capecitabine

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Metastatic Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Beth Israel Medical Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00459901

First Posted

April 11, 2007

Last Updated

April 28, 2015

Sponsor

Peter Kozuch

Collaborators

Hoffmann-La Roche, Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00459901

Brief Title

Study of the Antitumor Activity of Capecitabine in Combination With Erlotinib in Patients With Metastatic Colorectal Cancer

Official Title

Phase II Trial of OSI-774 (Erlotinib, Tarceva™,) and Capecitabine for Patients With Previously Untreated Metastatic Colorectal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Terminated

Why Stopped

Study halted by drug manufacturer

Study Start Date

June 2004 (undefined)

Primary Completion Date

June 2005 (Actual)

Study Completion Date

June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Peter Kozuch

Collaborators

Hoffmann-La Roche, Genentech, Inc.

4. Oversight

5. Study Description

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.

Detailed Description

Approximately 150,000 people are diagnosed with colorectal cancer in the United States each year. Forty to fifty thousand people eventually will develop metastatic colorectal cancer and 40,000 people die annually because of advanced or metastatic colorectal cancer. Cancer patients prefer oral therapy over intravenous therapy as palliative treatment if efficacy regarding response rate and response duration is not compromised. Therefore, development of a completely oral combination therapy that approximates or improves upon the clinical outcomes attained by the reference triple drug therapies should be a research priority. Compared with intravenous 5-fluourouracil/leucovorin as first-line treatment for metastatic colorectal cancer, oral capecitabine has demonstrated similar survival outcomes (approximately 12-13 months), response rates (15-20%), and response durations (4-5 months) in two multi-institutional international randomized phase III trials. Erlotinib (OSI-774, Tarceva) is an orally available inhibitor of human EGFR tyrosine kinase. The epidermal growth factor receptor (EGFR) is overexpressed in a variety of human cancers including colorectal cancer. The principal goal of anticancer treatment with tyrosine kinase inhibitors such as erlotinib is to restore normal cellular growth by interrupting EGFR mediated cell proliferation and malignant The hypothesis of this phase II trial is that the unique mechanisms of action and non-overlapping toxicity profiles of capecitabine (Xeloda) and erlotinib will allow these drugs to be combined into a safe and tolerable regimen with better activity regarding response, response duration, and median survival than capecitabine alone in patients with previously untreated metastatic colorectal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Colorectal Cancer

Keywords

Metastatic Colorectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Erlotinib and capecitabine

Primary Outcome Measure Information:

Title

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Kozuch, MD

Organizational Affiliation

Continuum Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beth Israel Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

10629633

Citation

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.

Results Reference

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Study of the Antitumor Activity of Capecitabine in Combination With Erlotinib in Patients With Metastatic Colorectal Cancer

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