- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00871273
Pharmacokinetic Study of Capecitabine After Total Gastrectomy for Stomach Adenocarcinoma
A Pharmacokinetic Study of Capecitabine in Patients Undergoing Peri-operative Chemotherapy and a Total Gastrectomy for Adenocarcinoma of the Stomach
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Objective:
- To establish the pharmacokinetics (PK) of capecitabine in patients who have undergone a total gastrectomy
Secondary Objectives:
- To compare the pharmacokinetic profile of capecitabine administered to patients with gastric cancer pre- and post-gastrectomy and to compare this to historical data of capecitabine PK values in patients with other cancer types.
- To ensure equivalent capecitabine exposure when compared to PK data from the same patients prior to gastrectomy.
This is a clinical trial to evaluate the pharmacokinetics (PK) of capecitabine in patients who have undergone a total gastrectomy. The study also aims to establish the toxicity profile of capecitabine in these patients, to identify any dose limiting toxicities (DLT), and to ensure equivalent capecitabine exposure when compared to PK data from the same patients prior to gastrectomy. Screening tests will consist of demographic details, complete medical history, physical exam, vital signs, tumour serum markers, haematology and biochemistry tests. There will also be an ECG, chest X-Ray or CT thorax, CT abdomen and a serum or urine pregnancy test (for women of childbearing potential). Haematology and Biochemistry will be repeated prior to each study drug administration. All patients will receive 6 cycles of oral capecitabine chemotherapy at a dose of 625 mg/m2, administered twice daily at 12 hourly intervals for 21 consecutive days. Total proposed duration of therapy is 3 cycles pre-operatively and 3 cycles post-operatively. Capecitabine and its metabolites (DFCR, DFUR and 5-FU) plasma levels will be measured during the 1st and 4th cycles in all patients. Treatment should continue for 6 cycles unless there is evidence of disease progression, or unacceptable toxicity.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Cambridge, United Kingdom
- Cambridge University Hospitals NHS Foundation Trust, University of Cambridge Oncology Centre
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Edinburgh, United Kingdom
- Edinburgh Cancer Centre, Western General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must have histologically confirmed gastric carcinoma suitable for potentially curative resection.
- Surgery must be planned to involve a total gastrectomy.
- No concurrent mechanical or malabsorptive disorders precluding affective oral administration of the drug (excluding early satiety related to the presence of the malignancy).
- Age ≥ 18 years.
- World Health Organisation (WHO) performance status of ≤ 2 (Appendix 1).
- Haematological and biochemical indices (These measurements must be performed within one week prior to the patient going on study.)
- Haemoglobin (Hb) ≥ 9.0 g/dl
- Neutrophils ≥ 1.5 x 109/L
- Platelets (Plts) ≥ 100 x 109/L
- Serum bilirubin ≤ 1.5 x upper normal limit
- Alanine amino-transferase (ALT) and / or aspartate amino-transferase (AST) ≤ 2.0 x upper limit of normal (ULN). (If both are measured, both must be ≤ 2.0 x ULN)
- Calculated creatinine clearance ≥ 50 ml/min (uncorrected value) or isotope clearance measurement ≥ 50ml/min
- Female patients of child-bearing potential must have a negative serum or urine pregnancy test prior to enrolment and agree to use appropriate medically approved contraception for four weeks prior to entering the trial, during the trial, and for six months afterwards.
- Male patients must agree to use appropriate medically approved contraception during the trial and for six months afterwards.
- Written, informed consent provided.
- Ability of the patient to co-operate with treatment and follow up must be ensured.
- Patients receiving oral anti-coagulation prior to entry into the study, must be converted to low molecular weight heparin in light of the interaction between capecitabine and warfarin.
Exclusion Criteria:
- Patients with gastric lymphoma or other histological diagnosis
- Any evidence of malignant ascites, peritoneal or liver metastasis, spread to other distant abdominal or extra-abdominal organs.
- History of confirmed Ischaemic Heart Disease, concurrent congestive heart failure or prior history of class III / IV cardiac disease (Appendix 2 - New York Heart Association (NYHA) Scale)
- Concurrent mechanical or malabsorptive disorders precluding effective oral administration of the drug
- Use of other concomitant chemotherapy
- Pregnancy or Lactation
- Patients known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
- Patients who are high medical risks because of non-malignant systemic disease including active uncontrolled infection.
- Any other serious medical or psychological condition precluding adjuvant treatment
- Patients with any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To establish the pharmacokinetics (PK) of capecitabine in patients who have undergone a total gastrectomy.
Time Frame: Samples collected predose and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, and 24 hours on day 1 of cycles 1 and 4
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Samples collected predose and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, and 24 hours on day 1 of cycles 1 and 4
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare the pharmacokinetic profile of capecitabine administered to patients with gastric cancer pre- and post-gastrectomy and to compare this to historical data of capecitabine PK values in patients with other cancer types.
Time Frame: 1 year
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1 year
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To ensure equivalent capecitabine exposure when compared to PK data from the same patients prior to gastrectomy.
Time Frame: 1 Year
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1 Year
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Collaborators and Investigators
Investigators
- Principal Investigator: Duncan Jodrell, DM MSc FRCP, Cambridge University Hospitals, NHS Foundation Trust, University of Cambridge
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAP002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adenocarcinoma of the Stomach
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Accelerated Community Oncology Research NetworkAmgenTerminatedGastroesophageal Adenocarcinoma | Adenocarcinomas of the Gastroesophageal Junction | Adenocarcinoma of the Distal Esophagus | Adenocarcinoma of the Proximal StomachUnited States
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UNICANCERBayerTerminatedAdenocarcinoma of the Gastroesophageal Junction | Adenocarcinoma of the StomachFrance
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National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric CancerUnited States
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National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric CancerUnited States
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National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Adenocarcinoma of the Esophagus | Recurrent Esophageal Cancer | Stage IV Esophageal Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma...United States
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Royal Marsden NHS Foundation TrustEli Lilly and Company; AstraZeneca; Clovis Oncology, Inc.; MedImmune LLCRecruitingAdenocarcinoma of the Stomach | Adenocarcinoma of the Oesophagus | Adenocarcinoma of the Gastro-oesophageal JunctionUnited Kingdom
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National Cancer Institute (NCI)CompletedStage IV Gastric Cancer | Recurrent Gastric Cancer | Stage III Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the StomachUnited States
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National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIB Gastric Cancer | Stage IIIC Gastric CancerUnited States
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Eastern Cooperative Oncology GroupNational Cancer Institute (NCI); ECOG-ACRIN Cancer Research GroupWithdrawnGastrointestinal Cancer | Adenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Adenocarcinoma of the Esophagus | Stage IV Esophageal Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric... and other conditionsUnited States
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