A Phase II Trial Evaluating Irinotecan Plus 5FU/LV in Patients With Relapsed/Refractory Upper GI Tumours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00220064
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 31, 2013
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Brief Summary:

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 or disease Intervention/treatment Phase
Upper Gastrointestinal Tumours Drug: Irinotecan, 5-Fluorouracil, Leucovorin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase II Trial Evaluating Irinotecan With 5_fluorouracil Plus Leucovorin in Patients With Relapsed/Refractory Upper Gastrointestinal Tumours
Study Start Date : July 2000
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Disease stabilization rate or tumour marker response

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00220064

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

Responsible Party: Royal Marsden NHS Foundation Trust Identifier: NCT00220064     History of Changes
Other Study ID Numbers: 1810
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 31, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Digestive System Neoplasms
Gastrointestinal Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs