Status:
COMPLETED
Phase II Fixed Dose Rate Gemcitabine for Advanced or Metastatic Colorectal Cancer
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To assess the efficacy and safety of gemcitabine given by fixed dose rate intravenous infusion in patients with pretreated metastatic colorectal cancer.
Detailed Description
Previous lines of treatment recorded. Adjuvant and palliative. Treatment will continue until clinical indication due to PD or toxicity, or until completion of 6 cycles of gemcitabine, whichever comes...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00220155
Start Date
May 1 2004
Last Update
December 16 2009
Active Locations (1)
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1
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT