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

Study Overview
=================
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 first. All patients will be assessed for toxicity and followed up for disease recurrence/progression. The study will be divided into two accrual stages - the first consisting of 17 patients. If 6 or more patients achieve tumour response or stabilisation in the first stage, the second stage will commence accrual of a further 20 patients. Hence, the total planned accrual will be 37 patients.

Official Title
-----------------
A Phase II Trial of Fixed Dose Rate Gemcitabine in Patients With Advanced or Metastatic Colorectal Cancer.

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Gemcitabine


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gemcitabine|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients obtaining disease control in the form of tumour response or stabilisation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment related toxicity |  |  | 
| Progression free survival |  |  |