Phase II Fixed Dose Rate Gemcitabine for Advanced or Metastatic Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00220155
- Lead Sponsor
- Royal Marsden NHS Foundation Trust
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Proportion of patients obtaining disease control in the form of tumour response or stabilisation
- Secondary Outcome Measures
Name Time Method Treatment related toxicity Progression free survival
Trial Locations
- Locations (1)
Royal Marsden Hospital
🇬🇧Sutton, Surrey, United Kingdom