Erlotinib and Chemotherapy for 2nd Line Treatment (Tx) of Metastatic Colorectal Cancer (mCRC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Genentech
OSI Pharmaceuticals
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00642746
First received: March 24, 2008
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to see if alternating chemotherapy with erlotinib increases tumor shrinkage in people with metastatic colorectal cancer. The investigator will also be studying the side effects (good and bad) of alternating chemotherapy with erlotinib on metastatic colorectal cancer.


Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: Erlotinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Erlotinib (Tarceva) Alternating With Chemotherapy for Second-line Treatment of Metastatic Colorectal Cancer With Molecular Correlates for p53 Pathway

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Demonstrate safety and efficacy of sequencing chemotherapy with erlotinib in the second-line treatment for metastatic colorectal cancer. [ Time Frame: Two to six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: March 2008
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib Drug: Erlotinib

Erlotinib oral tablets are conventional, immediate-release tablets containing erlotinib as the hydrochloride salt. In addition to the active ingredient, erlotinib contains lactose (hydrous), microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, and magnesium stearate.

Tablets containing 25 mg, 100 mg, and 150 mg of erlotinib are available. Each bottle will contain 30 tablets, a quantity sufficient for 4 consecutive weeks of dosing, with overage.

Other Name: Tarceva

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must fulfill all of the following criteria to be eligible for study entry:

  • Age 18-80
  • Able to provide informed consent
  • Biopsy proven unresectable metastatic adenocarcinoma of the colon or rectum
  • Documented progression on prior first-line oxaliplatin-based or irinotecan-based regimen for metastatic colorectal cancer
  • Radiographically measurable disease with at least one bidimensionally measurable lesion of > 1 cm
  • Prior first-line regimen must have been completed at least 4 weeks prior to study treatment
  • Use of biologic agents with first-line chemotherapy permitted
  • Previous adjuvant regimens must have been greater than 6 months before inclusion
  • Adequate organ function including bone marrow, liver and renal function as defined by the following values: absolute neutrophil count > 1500/uL; Hgb > 9 g/dL; platelets > 90,000/uL; INR < 1.8 (unless in therapeutic range if taking warfarin or other warfarin-derivative anticoagulants and are being monitored regularly for changes in prothrombin time or INR); bilirubin < 2X ULN; alkaline phosphatase < 3X ULN; AST/ALT < 5X ULN; serum creatinine < 1.5 X ULN
  • ECOG status < 2

Exclusion Criteria:

Patients meeting any of the following criteria are ineligible for study entry:

  • Prior second-line chemotherapy regimens for colorectal cancer
  • Prior treatment with erlotinib or gefitinib
  • CNS metastasis
  • Second malignancies less than 5 years prior to enrollment. Completely resected basal or squamous cell carcinoma of the skin is allowed.
  • Untreated/unresolved bowel obstruction
  • Inability to take oral mediations
  • HIV positive
  • Pregnancy
  • Other uncontrolled medical illnesses
  • Current diarrhea > grade 2
  • Symptomatic angina or uncontrolled congestive heart failure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642746

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
Genentech
OSI Pharmaceuticals
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00642746     History of Changes
Other Study ID Numbers: 3753
Study First Received: March 24, 2008
Last Updated: May 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by OHSU Knight Cancer Institute:
Colon
Cancer
Metastatic
Colorectal

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014