Clinical trial · Interventional
ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer
A Phase I Study Of ZD1839 (Iressa) In Combination With Irinotecan, Leucovorin, And 5-Fluorouracil In Previously Untreated, Stage IV Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| gefitinib | Drug | Gefitinib | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral ZD 1839 daily. Beginning on day 15, patients receive irinotecan IV over 90 minutes, leucovorin calcium IV over 15 minutes, and fluorouracil IV weekly on weeks 1-2. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ZD 1839 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are accrued to receive treatment at the MTD.
- interventionNames
- Drug: fluorouracil
- Drug: gefitinib
- Drug: irinotecan hydrochloride
- Drug: leucovorin calcium
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTMeyerhardt JA, Clark JW, Supko JG, Eder JP, Ogino S, Stewart CF, D'Amato F, Dancey J, Enzinger PC, Zhu AX, Ryan DP, Earle CC, Mayer RJ, Michelini A, Kinsella K, Fuchs CS. Phase I study of gefitinib, irinotecan, 5-fluorouracil and leucovorin in patients with metastatic colorectal cancer. Cancer Chemother Pharmacol. 2007 Oct;60(5):661-70. doi: 10.1007/s00280-006-0411-6. Epub 2007 Jan 11. PMID 17216531
- RESULTWolpin BM, Clark JW, Meyerhardt JA, Earle CC, Ryan DP, Enzinger PC, Zhu AX, Blaszkowsky L, Battu S, Fuchs CS. Phase I study of gefitinib plus FOLFIRI in previously untreated patients with metastatic colorectal cancer. Clin Colorectal Cancer. 2006 Sep;6(3):208-13. doi: 10.3816/CCC.2006.n.037. PMID 17026790