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Phase II Trial Evaluating Irinotecan and Capecitabine 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
Sponsored by: Royal Marsden NHS Foundation Trust
Information provided by: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00220168
  Purpose

The objective of this study is to assess the efficacy and toxicity of a 3 weekly regimen containing irinotecan combined with capecitabine in the setting of relapsed or refractory upper gastrointestinal tumours. Patients with locally advanced or metastatic adenocarcinoma or squamous cell carcinoma originating from the oesophagus, oesophagogastric junction or stomach who have previously received chemotherapy and have either failed to respond or who have relapsed within 3 months after an initial response will be eligible for treatment in this study.

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


Condition Intervention Phase
Upper Gastrointestinal Tumours
Drug: Irinotecan, Capecitabine
Phase IV

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Trial Evaluating Irinotecan and Capecitabine 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:
  • Response rates
  • Time to disease progression (TTP)

Secondary Outcome Measures:
  • Survival
  • Quality of life
  • Toxicity (incidence of febrile neutropenia, in-patient admissions, severity of diarrhea, mucositis, aesthesia, transfusion requirements).

Estimated Enrollment: 33
Study Start Date: January 2003
  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 oesophagus, O-G junction and stomach, not amenable to surgical resection.
  • Bidimensionally measurable disease, or unidimensional measurable disease assessable 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 within 3 months 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. Creatinine clearance (measured by Cockcroft and Gault) >50ml/min and Cr <135.
  • 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
  • Creatinine clearance <50ml/min, Cr >135
  • 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: NCT00220168

Locations
United Kingdom, Surrey
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

Study ID Numbers: 2166
Study First Received: September 19, 2005
Last Updated: October 10, 2006
ClinicalTrials.gov Identifier: NCT00220168     History of Changes
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:
Antimetabolites
Capecitabine
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Irinotecan
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Irinotecan
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 11, 2009