Phase II Fixed Dose Rate Gemcitabine for Advanced or Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy and safety of gemcitabine given by fixed dose rate intravenous infusion in patients with pretreated metastatic colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Marsden NHS Foundation Trust
• Treatments: Gemcitabine

Criteria

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.