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

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

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

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

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.

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

- 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

- Patients within 4 weeks of chemotherapy or radiotherapy (6 weeks for nitrosureas or
mitomycin C).

- Previous treatment with gemcitabine.

- Patients with uncontrolled cerebral metastases.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients obtaining disease control in the form of tumour response or stabilisation

Principal Investigator

David Cunningham

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

May 2004

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms