Clinical trial NCT00052585 (phase 2, status: terminated)
Conditions: adenocarcinoma of the colon, adenocarcinoma of the rectum, mucinous adenocarcinoma of the colon, mucinous adenocarcinoma of the rectum, recurrent colon cancer, recurrent rectal cancer, signet ring adenocarcinoma of the colon, signet ring adenocarcinoma of the rectum, stage iv colon cancer, stage iv rectal cancer
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C18.2, C18.4, C18.6, C18.7, C18.9, D12.2, D12.3, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2
Drugs: irinotecan hydrochloride, gefitinib, leucovorin calcium, fluorouracil
SMILES: CCC1=C2CN3C(=CC4=C(COC(=O)[C@]4(O)CC)C3=O)C2=NC2=CC=C(OC(=O)N3CCC(CC3)N3CCCCC3)C=C12, COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1, NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    administratively complete.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed advanced (stage IV) or recurrent adenocarcinoma of the colon
             or rectum

          -  Must have available tissue for immunohistochemical analysis

          -  At least one unidimensionally measurable lesion

               -  At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

               -  Tumor marker (carcinoembryonic antigen) elevation alone is insufficient for study
                  entry

          -  No known brain metastases

          -  Performance status - ECOG 0-2

          -  Granulocyte count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  AST less than 2 times ULN (5 times ULN if liver involvement of tumor)

          -  Creatinine no greater than 1.5 times ULN

          -  No symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No cardiac arrhythmia

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  HIV negative

          -  No other severe or uncontrolled concurrent illness that would adversely impact the
             safety or efficacy of study therapy

          -  No ongoing or active infection

          -  No other prior malignancy unless curatively treated and no evidence of recurrence

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to gefitinib

          -  No psychiatric illness or social situation that would preclude study compliance

          -  No prior chemotherapy for advanced disease

          -  More than 4 weeks since other prior chemotherapy (6 weeks for nitrosoureas or
             mitomycin) and recovered

          -  More than 4 weeks since prior radiotherapy and recovered

          -  At least 6 months since prior adjuvant therapy

          -  No prior epidermal growth factor receptor inhibitor

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapy

          -  No concurrent phenytoin, carbamazepine, barbiturates, rifampin, rifapentine,
             oxacarbazepine, modafinil, griseofulvin, or Hypericum perforatum