Erlotinib and Chemotherapy for 2nd Line Treatment (Tx) of Metastatic Colorectal Cancer (mCRC)
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Erlotinib; Fluorouracil; Leucovorin; Oxaliplatin; Irinotecan
Intervention description: 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.; Antimetabolite used as a chemotherapy. Administered intravenously as a bolus injection at 400mg/m2 on Day 1 followed by 2400 mg/m2 continuously over 46 hours.; Chemotherapy agent given as a supplement to Fluorouracil. Given intravenously 400mg/m2 in combination with Fluorouracil dosing.; Platinum-based antineoplastic chemotherapy agent given intravenously at 85 mg/m2.; Chemotherapy agent given intravenously at 180 mg/m2.
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Irinotecan; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Colon; Cancer; Metastatic; Colorectal

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