ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase I trial to study the effectiveness of ZD 1839 combined with irinotecan, leucovorin, and fluorouracil in treating patients who have locally advanced, locally recurrent, or metastatic colorectal cancer. Biological therapies such as ZD 1839 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 ZD 1839 with combination chemotherapy may kill more tumor cells.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Calcium; Fluorouracil; Gefitinib; Irinotecan; Leucovorin; Levoleucovorin

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the colon or rectum

• Locally advanced, locally recurrent, or metastatic disease

• Not curable by surgery and/or not amenable to radiotherapy with curative intent

• Histological or cytological confirmation of metastatic cancer not required for patients with prior surgically resected colorectal cancer if more than 5 years elapsed between primary surgery and development of metastatic disease OR if primary cancer was stage I or II

• Prior adjuvant therapy with fluorouracil or immunotherapy for resected stage II, III, or IV disease allowed

• Measurable disease

• No known brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• More than 12 weeks

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 normal

• AST/ALT no greater than 5 times upper limit of normal

Renal:

• Creatinine normal

Cardiovascular:

• No uncontrolled high blood pressure

• No unstable angina

• No symptomatic congestive heart failure

• No myocardial infarction within the past 6 months

• No serious uncontrolled cardiac arrhythmia

• No New York Heart Association class III or IV heart disease

Other:

• No active or uncontrolled infection

• No predisposing colonic or small bowel disorders with uncontrolled symptoms as indicated by more than 3 loose stools daily in patients without a colostomy or ileostomy

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinomas

• No other concurrent medical or psychiatric condition that would preclude study

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 12 months since prior immunotherapy

Chemotherapy:

• At least 12 months since prior fluorouracil

• No prior chemotherapy for advanced colorectal cancer

• No prior irinotecan

Radiotherapy:

• No prior radiotherapy to more than 15% of bone marrow

• At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative radiotherapy)

• No concurrent radiotherapy

Surgery:

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

• At least 2 weeks since prior minor surgery and recovered

• No concurrent ophthalmic surgery

Other:

• No prior ZD 1839

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

• No concurrent combination antiretroviral therapy for HIV

• No concurrent oral retinoids

• No concurrent prochlorperazine on day of irinotecan administration