Clinical trial · Interventional
Gefitinib in Treating Patients With Recurrent Metastatic Colorectal Cancer
A Randomized Phase II Trial of Two Dose Levels of ZD1839 (Iressa) (NSC 715055, IND 61187) in Patients With Recurrent Colorectal Adenocarcinoma
NCT00025350CI-TRIAL-00010966completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of recurrent metastatic colorectal cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of two different doses of gefitinib in treating patients who have recurrent metastatic colorectal cancer.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gefitinib | Drug | Gefitinib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically proven adenocarcinoma of the colon or rectum * Measurable disease * Evidence of new or progressive metastatic disease within 6 months of last treatment * Must have received prior systemic treatment with fluorouracil (and/or its analogs, with or without leucovorin calcium or levamisole) and irinotecan in the adjuvant or metastatic setting * Metastatic tumor site accessible for biopsy * No known brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * More than 12 weeks 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 times upper limit of normal (ULN) * AST or ALT no greater than 2.5 times ULN (5 times ULN if tumor involvement of the liver) Renal: * Creatinine no greater than 1.5 times ULN OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No New York Heart Association class III or IV heart disease * 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 active or uncontrolled infections * Other prior malignancies allowed provided prior therapy is discontinued and no evidence of disease * No other uncontrolled illness or psychiatric illness/social situations that would preclude study * Must be able to take and retain oral medications PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior signal transduction inhibitors (e.g., vascular endothelial growth factor-, vascular endothelial growth factor receptor-, and epidermal growth factor receptor-targeted agents) for colorectal cancer Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy and recovered * No other prior cytotoxic chemotherapy (e.g., oxaliplatin) for colorectal cancer Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered Surgery: * Not specified Other: * No other prior systemic therapy for colorectal cancer * No other prior investigational or approved agents for colorectal cancer * No other concurrent investigational agents * No concurrent antiretroviral therapy for HIV-positive patients
References
Publications (2)
- RESULTRothenberg ML, LaFleur B, Levy DE, Washington MK, Morgan-Meadows SL, Ramanathan RK, Berlin JD, Benson AB 3rd, Coffey RJ. Randomized phase II trial of the clinical and biological effects of two dose levels of gefitinib in patients with recurrent colorectal adenocarcinoma. J Clin Oncol. 2005 Dec 20;23(36):9265-74. doi: 10.1200/JCO.2005.03.0536. PMID 16361624
- RESULTRothenberg ML, Lafleur B, Washington MK, et al.: Changes in epidermal growth factor receptor signaling in serum and tumor biopsies obtained from patients with progressive metastatic colorectal cancer (MCRC) treated with gefitinib (ZD1839): an Eastern Cooperative Oncology Group study. [Abstract] J Clin Oncol 22 (Suppl 14): A-3000, 195s, 2004.