Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00220064
First received: September 19, 2005
Last updated: May 30, 2013
Last verified: May 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

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

Enrollment: 65
Study Start Date: July 2000
Study Completion Date: November 2005
  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
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: 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

Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00220064     History of Changes
Other Study ID Numbers: 1810
Study First Received: September 19, 2005
Last Updated: May 30, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Digestive System Neoplasms
Gastrointestinal Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms
Neoplasms by Site
Fluorouracil
Irinotecan
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014