search
Back to results

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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Gemcitabine
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Royal Marsden Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Treatment related toxicity
Progression free survival

Full Information

First Posted
September 20, 2005
Last Updated
December 15, 2009
Sponsor
Royal Marsden NHS Foundation Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT00220155
Brief Title
Phase II Fixed Dose Rate Gemcitabine for Advanced or Metastatic Colorectal Cancer
Official Title
A Phase II Trial of Fixed Dose Rate Gemcitabine in Patients With Advanced or Metastatic Colorectal Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Royal Marsden NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Primary Outcome Measure Information:
Title
Proportion of patients obtaining disease control in the form of tumour response or stabilisation
Secondary Outcome Measure Information:
Title
Treatment related toxicity
Title
Progression free survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Cunningham
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs