Clinical trial · Interventional
Gemcitabine in Treating Patients With Advanced Colorectal Cancer
A Phase II Study Of Twenty-Four Hour Infusion Gemcitabine For Advanced Colorectal Cancer
NCT00007943CI-TRIAL-00053805completedPhase 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have advanced 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 |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically confirmed advanced colorectal cancer that has failed at least 1 prior course of fluoropyrimidine-based chemotherapy Measurable and/or evaluable disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * 0-2 Life expectancy: * At least 3 months Hematopoietic: * WBC at least 3,000/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than 2.5 times upper limit of normal (ULN) * ALT and/or AST no greater than 3 times ULN (no greater than 10 times ULN if * secondary to hepatic involvement by tumor Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No history of cardiac arrhythmias requiring chronic treatment beyond an * acute event (e.g., arrhythmias during severe electrolyte abnormalities * allowed) * No active cardiac disease requiring treatment other than hypertension, * stable angina, or chronic valvular disease Other: * No other malignancy within the past 5 years except curatively treated * (including surgically cured) cancer * No serious medical or psychiatric illness that would preclude study * No active uncontrolled bacterial, fungal, or viral infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No more than 3 prior chemotherapy regimens * Must have 1 prior fluorouracil-based regimen and 1 other cytotoxic agent * (e.g., irinotecan) * More than 4 weeks since prior chemotherapy * Prior gemcitabine allowed * No other concurrent antineoplastic therapy Endocrine therapy: * Not specified Radiotherapy: * More than 4 weeks since prior radiotherapy Surgery: * More than 4 weeks since prior surgery
References
Publications (0)
Data not yet available
No reference posted for this study.