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A Phase II Trial Evaluating Irinotecan Plus 5FU/LV in Patients With Relapsed/Refractory Upper GI Tumours
This study is ongoing, but not recruiting participants.
First Received: September 19, 2005   Last Updated: October 10, 2006   History of Changes
Sponsors and Collaborators: Royal Marsden NHS Foundation Trust
Aventis Pharmaceuticals
Information provided by: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00220064
  Purpose

The objective of this study is to assess the efficacy and toxicity of a 2 weekly regimen containing irinotecan combined with leucovorin-modified 5-fluorouracil in the setting of relapsed or refractory upper gastrointestinal tumours. Patients with locally advanced or metastatic adenocarcinoma originating from the oesophagogastric junction, stomach or pancreas who have previously received chemotherapy and have either failed to respond or who have relapsed after an initial response will be eligible for treatment in this study.

The response rate, failure-free survival and overall survival of treated patients with the two different regimes will be evaluated. Toxicity and quality of life will also be monitored closely.


Condition Intervention Phase
Upper Gastrointestinal Tumours
Drug: Irinotecan, 5-Fluorouracil, Leucovorin
Phase II

Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Trial Evaluating Irinotecan With 5_fluorouracil Plus Leucovorin in Patients With Relapsed/Refractory Upper Gastrointestinal Tumours

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Disease stabilization rate or tumour marker response

Estimated Enrollment: 65
Study Start Date: July 2000
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven adenocarcinoma or squamous cell carcinoma of the Oesophagus, O-G junction, stomach and pancreas, not amenable to surgical resection.
  • Bidimensionally measurable disease, or unidimensional measurable disease accessible by CT scanning, not within previously irradiated areas.
  • Patients with progressive disease during previous chemotherapy treatment or within three months of stopping treatment.
  • At least one previous chemotherapy regimen, given at least 4 weeks prior to inclusion in this study.
  • No previous exposure to irinotecan.
  • Adequate bone marrow function with platelets >100 X 109/L; WBC > 3 X 109/L; Neutrophils > 1.5 X 109/L at the time of study entry.
  • Satisfactory renal function, serum creatinine  135 mol/litre
  • Satisfactory liver function:
  • In the absence of liver metastases:- Bilirubin < 1.25N (N=upper limit of normal range) Hepatic transaminases < 2.5N Prothrombin time < 1.5N
  • In the presence of liver metastases:- Bilirubin < 1.5N Hepatic transaminases < 5N Prothrombin time < 1.5N
  • No uncontrolled medical condition
  • No previous malignant disease except for non-melanotic skin cancer or in-situ carcinoma of the uterine cervix.
  • ECOG performance status of 0, 1 or 2.
  • Predicted life expectancy of > 3 months.
  • Adequate contraceptive precautions
  • Informed written consent

Exclusion Criteria:

  • Medical or psychiatric conditions resulting in inability of patient to give written consent.
  • ECOG Performance status >2
  • Intracerebral metastases or meningeal carcinomatosis
  • Unresolved bowel obstruction
  • Uncontrolled angina pectoris, heart failure (New York heart classification 3 or 4).
  • Pregnancy/lactation
  • Previous malignancy other than adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220064

Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Aventis Pharmaceuticals
Investigators
Principal Investigator: David Cunningham Royal Marsden NHS Foundation Trust
  More Information

No publications provided

Study ID Numbers: 1810
Study First Received: September 19, 2005
Last Updated: October 10, 2006
ClinicalTrials.gov Identifier: NCT00220064     History of Changes
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:
Antimetabolites
Digestive System Neoplasms
Vitamin B Complex
Immunologic Factors
Gastrointestinal Diseases
Irinotecan
Leucovorin
Trace Elements
Folinic Acid
Immunosuppressive Agents
Digestive System Diseases
Fluorouracil
Vitamins
Gastrointestinal Neoplasms
Micronutrients
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Antimetabolites
Vitamin B Complex
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Growth Substances
Physiological Effects of Drugs
Irinotecan
Leucovorin
Enzyme Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Vitamins
Therapeutic Uses
Fluorouracil
Gastrointestinal Neoplasms
Micronutrients
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 11, 2009