Clinical trial NCT00026299 (phase 1/phase 2, status: completed)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: zd1839, oxaliplatin
SMILES: 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
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that
             is not amenable to potentially curative surgical resection

          -  Metastatic or locally recurrent disease

          -  Tumor in liver or lung accessible to needle biopsy by ultrasound or CT scan guidance

          -  At least 1 measurable lesion

               -  At least 20 mm by conventional techniques, including physical examination, CT
                  scan, or MRI OR

               -  At least 10 mm by spiral CT scan

               -  Lesions on colonoscopic examination or barium studies, bone metastases, CNS
                  lesions, and ascites are not considered measurable

          -  Failed prior therapy with fluorouracil, leucovorin calcium, and irinotecan given
             either sequentially or in combination

          -  No known brain metastases

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  ECOG 0-2

        Life expectancy:

          -  At least 3 months

        Hematopoietic:

          -  WBC at least 3,000/mm^3

          -  Absolute neutrophil count at least 1,500/mm^3

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

        Hepatic:

          -  Bilirubin no greater than 1.5 mg/dL

          -  AST/ALT no greater than 2.5 times upper limit of normal

        Renal:

          -  Creatinine no greater than 1.5 mg/dL OR

          -  Creatinine clearance at least 60 mL/min

        Cardiovascular:

          -  No symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No cardiac arrhythmia

        Other:

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No peripheral neuropathy greater than grade 1

          -  No other concurrent uncontrolled illness that would preclude study

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

          -  No ongoing or active infection

          -  No prior allergic reaction to compounds of similar chemical or biologic composition to
             oxaliplatin or gefitinib

          -  No other concurrent malignancy except non-melanoma skin cancer or carcinoma in situ of
             the cervix unless considered to be at less than 30% risk of relapse after completion
             of therapy

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No prior epidermal growth factor inhibitor

          -  At least 24 hours since prior colony-stimulating factors

          -  No concurrent colony-stimulating factors during first course of study therapy

        Chemotherapy:

          -  See Disease Characteristics

          -  No more than 2 prior chemotherapy regimens for metastatic disease

          -  Prior adjuvant chemotherapy allowed

          -  At least 4 weeks since prior cytotoxic chemotherapy and recovered

          -  No prior cisplatin or oxaliplatin

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  At least 4 weeks since prior radiotherapy and recovered

        Surgery:

          -  See Disease Characteristics

          -  At least 4 weeks since prior surgery

        Other:

          -  At least 30 days since prior investigational agents

          -  Recovered from prior therapy

          -  No concurrent anti-retroviral therapy for HIV

          -  No other concurrent investigational or commercial agents or therapies for malignancy