Clinical trial NCT00642746: Erlotinib and Chemotherapy for 2nd Line Treatment (Tx) of Metastatic Colorectal Cancer (mCRC)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: Colon
Cancer
Metastatic
Colorectal
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: OSI Pharmaceuticals
First posted: 2008-03-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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/microliter; Hgb \> 9 g/dL; platelets \> 90,000/microliter; International Normalized Ratio \< 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 International Normalized Ratio); bilirubin \< 2 times the Upper Limit of Normal; alkaline phosphatase \< 3 times the Upper Limit of Normal; aspartate aminotransferase/alanine aminotransferase \< 5 times the Upper Limit of Normal; serum creatinine \< 1.5 times the Upper Limit of Normal
* Eastern Cooperative Oncology Group 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
* Central Nervous System 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

Primary outcomes:
measure: Response Rates of Radiographically Measurable Disease
timeFrame: Disease response assessed after every 2 Treatment Cycles, or around 8 weeks.
Secondary outcomes:
measure: Second-line Progression Free Survival
timeFrame: Upon completion of follow-up, for an average of 99 days following the initiation of study treatment.
measure: Time to Second Progression (From Start of First-Line Regimen)
timeFrame: Documented by Follow-up CT scans following first line treatment, average of 225 days.
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References: