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

Royal Marsden NHS Foundation Trust

Status and phase

Completed

Phase 2

Conditions

Colorectal Cancer

Treatments

Drug: Gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT00220155

2398

Details and patient eligibility

About

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

Full 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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.