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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00220155
• Other study ID #: 2398
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2005
• Last updated: December 15, 2009
• Start date: May 2004

Study information

• Verified date: December 2009
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Gemcitabine

Locations

Country	Name	City	State
United Kingdom	Royal Marsden Hospital	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients obtaining disease control in the form of tumour response or stabilisation
Secondary	Treatment related toxicity
Secondary	Progression free survival