A Phase I/ Randomized Phase II Trial Of Oxaliplatin (NSC #266046) With Or Without ZD 1839 (NSC # 715055) In Patients With Advanced Colorectal Carcinoma

Inclusion 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