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

This study has been completed.
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00220155
First received: September 20, 2005
Last updated: December 15, 2009
Last verified: December 2009
  Purpose

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


Condition Intervention Phase
Colorectal Cancer
Drug: Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Fixed Dose Rate Gemcitabine in Patients With Advanced or Metastatic Colorectal Cancer.

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

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

Enrollment: 16
Study Start Date: May 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220155

Locations
United Kingdom
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
  More Information

No publications provided

Responsible Party: Jane Lawrence, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00220155     History of Changes
Other Study ID Numbers: 2398
Study First Received: September 20, 2005
Last Updated: December 15, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 20, 2014