Gefitinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Colorectal Cancer

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug with gefitinib may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of gefitinib and oxaliplatin combined with leucovorin and fluorouracil in treating patients who have advanced solid tumors or colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Calcium; Fluorouracil; Gefitinib; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Phase I (closed as of 5/30/02):

• Histologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective

• Phase II:

• Histologically confirmed metastatic or unresectable colorectal adenocarcinoma

• Measurable disease or assessable but nonmeasurable disease (including ascites, pleural/pericardial effusions, lymphangitis cutis/pulmonis, inflammatory breast disease, abdominal masses (not followed by CT scan/MRI), or cystic lesions)

• Disease characterized only by elevated serum tumor marker allowed

• No known brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2 OR

• Karnofsky 60-100%

Life expectancy:

• More than 3 months

Hematopoietic:

• 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 normal 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 ongoing or active infection

• No peripheral neuropathy

• No prior allergic reactions to compounds of similar chemical or biologic composition to gefitinib or other study agents

• No other concurrent uncontrolled illness

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior bone marrow or stem cell support with high-dose chemotherapy

• At least 24 hours since prior colony-stimulating growth factors

Chemotherapy:

• See Biologic therapy

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

• No more than 3 prior chemotherapy regimens

Endocrine therapy:

• At least 2 weeks since prior hormonal therapy except megestrol for anorexia/cachexia

Radiotherapy:

• No prior pelvic or whole abdominal radiotherapy

• At least 4 weeks since other prior radiotherapy and recovered

Surgery:

• At least 4 weeks since prior major surgery (e.g., laparotomy) and recovered

Other:

• At least 4 weeks since prior investigational therapy

• No other concurrent investigational or commercial anticancer agents

• No concurrent combination antiretroviral therapy for HIV-positive patients