Clinical trial · Interventional
Phase II Fixed Dose Rate Gemcitabine for Advanced or Metastatic Colorectal Cancer
A Phase II Trial of Fixed Dose Rate Gemcitabine in Patients With Advanced or Metastatic Colorectal Cancer.
NCT00220155CI-TRIAL-00002901completedPhase 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)
To assess the efficacy and safety of gemcitabine given by fixed dose rate intravenous infusion in patients with pretreated 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 |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Proportion of patients obtaining disease control in the form of tumour response or stabilisation
Secondary outcomes (2)
- measure
- Treatment related toxicity
- measure
- Progression free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years * Histologically proven colorectal adenocarcinoma. * Locally advanced (inoperable) or metastatic colorectal carcinoma treated with at least one prior chemotherapy regimen. * Progressive disease documented by CT either during or within 3 months of completion of previous chemotherapy * No previous malignant disease other than non-melanotic skin cancer or carcinoma-in-situ of the uterine cervix. * Unidimensional measurable disease as assessed by CT. * Adequate bone marrow function; Hb \>10g/dl, platelets \>100 x109/l, WBC \>3x109/l, Neut \>1.5x109/l. * Adequate liver function: Serum Bilirubin \<1.5 x upper limit of normal * Adequate renal function: Serum Creatinine \< 0.11 mmol/L * No concurrent uncontrolled medical conditions * WHO performance status 0,1 or 2 * Adequate contraceptive precautions, if appropriate * Informed written consent * Negative pregnancy test in women of child bearing age * Life expectancy \> 3 months Exclusion Criteria: * Medical or psychiatric condition that comprise the patient's ability to take informed consent. * Patients within 4 weeks of chemotherapy or radiotherapy (6 weeks for nitrosureas or mitomycin C). * Previous treatment with gemcitabine. * Patients with uncontrolled cerebral metastases.
References
Publications (0)
Data not yet available
No reference posted for this study.