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

Sponsor
Royal Marsden NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT00220155
Collaborator
(none)
16
Enrollment
1
Location

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of Fixed Dose Rate Gemcitabine in Patients With Advanced or Metastatic Colorectal Cancer.
Study Start Date :
May 1, 2004

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients obtaining disease control in the form of tumour response or stabilisation []

Secondary Outcome Measures

  1. Treatment related toxicity []

  2. Progression free survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Royal Marsden Hospital Sutton Surrey United Kingdom SM2 5PT

Sponsors and Collaborators

  • Royal Marsden NHS Foundation Trust

Investigators

  • Principal Investigator: David Cunningham, Royal Marsden NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00220155
Other Study ID Numbers:
  • 2398
First Posted:
Sep 22, 2005
Last Update Posted:
Dec 16, 2009
Last Verified:
Dec 1, 2009
Additional relevant MeSH terms:
Colorectal Neoplasms
Gemcitabine

Study Results

No Results Posted as of Dec 16, 2009