Clinical trial NCT00087334 (phase 1/phase 2, status: terminated)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: capecitabine, gefitinib, oxaliplatin
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    withdrawn due to poor/low accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed* colorectal cancer

               -  Metastatic disease

               -  The site of the primary tumor must have been confirmed endoscopically,
                  radiologically, or surgically to be the colon or rectum NOTE: *Confirmation is
                  not required for recurrent metastatic disease unless an interval of > 5 years has
                  elapsed between the initial primary surgery and the development of metastases

          -  Measurable disease

               -  At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques
                  OR ≥ 10 mm by spiral CT scan

          -  No CNS metastases

        PATIENT CHARACTERISTICS:

        Age

          -  18 to 80

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  More than 3 months

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9 g/dL (transfusion allowed)

        Hepatic

          -  AST and ALT ≤ 3 times upper limit of normal (ULN)

          -  Bilirubin ≤ ULN

          -  No unstable or uncompensated hepatic disease

        Renal

          -  Creatinine < 1.5 times ULN OR

          -  Creatinine clearance > 60 mL/min

          -  No unstable or uncompensated renal disease

        Cardiovascular

          -  No unstable or uncompensated cardiac disease

        Pulmonary

          -  No evidence of clinically active interstitial lung disease

               -  Asymptomatic patients with chronic stable radiographic changes are eligible

          -  No unstable or uncompensated respiratory disease

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after study
             participation

          -  No known hypersensitivity to gefitinib or any of its excipients

          -  No known hypersensitivity to platinum compounds, fluorouracil, or capecitabine

          -  No severe or uncontrolled systemic disease

          -  Able to receive oral medication

          -  No known dihydropyrimidine dehydrogenase (DPD) deficiency

          -  No known peripheral neuropathy ≥ grade 1

               -  Absence of deep tendon reflexes as the sole neurological abnormality allowed

          -  No other significant clinical disorder or laboratory finding that would preclude study
             participation

          -  No other malignancy within the past 5 years except basal cell skin cancer or carcinoma
             in situ of the cervix (phase II only)

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  At least 4 weeks since prior chemotherapy for metastatic colorectal cancer (phase I)

          -  No prior chemotherapy for metastatic disease (phase II)

               -  Prior fluorouracil and leucovorin calcium in the adjuvant setting allowed
                  provided the last treatment was administered more than 6 months before the
                  development of metastatic disease

          -  No prior irinotecan and oxaliplatin (phase II)

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No concurrent radiotherapy for colorectal cancer

        Surgery

          -  See Disease Characteristics

          -  More than 4 weeks since prior major surgery (e.g., laparotomy)

        Other

          -  Recovered from all prior therapy (no unresolved chronic toxicity > grade 2)

          -  More than 4 weeks since prior investigational drugs

          -  No prior epidermal growth factor receptor inhibitor therapy (phase II)

          -  No concurrent phenytoin, carbamazepine, rifampin, barbiturates, or Hypericum
             perforatum (St. John's wort)

          -  No other concurrent investigational drugs

          -  No other concurrent systemic therapy for colorectal cancer