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Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer

This study is currently recruiting participants.
Verified May 2013 by Chinese Academy of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Jing Jin, M.D., Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01584544
First received: April 20, 2012
Last updated: May 28, 2013
Last verified: May 2013
History of Changes
  Purpose

This phase I study is designed to determine the maximum tolerant dose of capecitabine when used in preoperative concurrent chemo-radiation for locally advanced rectal patients over 75 years old.


Condition Intervention Phase
Rectal Neoplasms
 Drug: capecitabine
Drug: Capecitabine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Preoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • number of patients suffering dose limited toxicity [ Time Frame: up to 7 weeks from start of the treatment ] [ Designated as safety issue: Yes ]
    more than 1/3 patients suffer DLT means the end of the trial.dose related toxicity is defined as follows:1. luecopenia > grade 2; granular cell decrease > grade 2; anemia > grade 1; platelet > grade 1;SGPT/SGOT elevation > grade 1; ALP > grade 1; GGT > grade 1; Tbil > grade 1;renal function damag > grade 2;Non-gradular cell decreased fever > grade 1;nausea/vomiting > grade 1; fatigue > grade 2; weight loss > grade 2;gastritis > grade 2; dairrea > grade 2; abdominal pain > grade 2; upper gastrointestinal bleeding > grade 1;other toxic reaction > grade 2;KPS < 50 during the treatment


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1000mg
capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.
 Drug: capecitabine
oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Name: stare 1
Experimental: 1200mg
capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
 Drug: Capecitabine
oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Name: stare 2
Experimental: 1350mg
capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
 Drug: Capecitabine
oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Name: stare 3
Experimental: 1500mg
capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
 Drug: Capecitabine
oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Name: stare 4
Experimental: 1650mg
capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
 Drug: Capecitabine
oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Other Name: stare 5

Detailed Description:

It is proved that preoperative concurrent chemo-radiotherapy can improve both local control and overall survival in stage II/III rectal cancer patients. But elderly patients, especially patients over 75 years were hardly involved in related clinical trials considered of their fragility.

Several retrospective study showed that old rectal cancer patients would also benefit from concurrent chemo-radiation, with acceptable toxicity. Several new drug, such as capecitabine, also seem to be safety for elderly cancer patients. But few prospective study has been carried out.

The investigators designed this phase I study, to explore the maximum tolerant dose of capecitabine in preoperative concurrent chemoradiation for elderly stage II/III rectal cancer patients, as well as to evaluate safety.

  Eligibility

Ages Eligible for Study:   76 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • rectal adenocarcinoma, clinical stage II/III(T3-4 or N+, AJCC 7th).
  • KPS status no less than 70; Charlson comorbidity no more than 3.
  • life expectancy more than 6 months.
  • hemoglobin >= 100g/L, white blood cell >= 3.5*10E9/L, neutrophil >= 1.5*10E9/L, platelet >= 100*10E9/L.Creatin normal, Total bilirubin normal, AST and AST normal, AKP normal.
  • do not have allergy history to thymidine phosphorylase.
  • do not receive surgery ( except palliative colostomy) or chemotherapy or other anti-cancer treatment
  • no previously pelvic irradiation history
  • informed consent signed

Exclusion Criteria:

  • other cancer history, except curable non-melanoma skin cancer or cervix in-situ carcinoma
  • previous pelvic irradiation history
  • receiving surgery (except palliative colostomy), chemotherapy or other anti-cancer treatment
  • allergy history to thymidine phosphorylase
  • active infection existed
  • severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes ( Plasma glucose concentrations in any time of a day≥11.1mmol/L）, severe cardiac arrhythmia， etc.
  • anticipate other clinical trials in four weeks before enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584544

Contacts
Contact: Yu Tang, Ph.D. 8613521662807 tangyu.pumc@gmail.com
Contact: Wenyang Liu, Ph.D. 8601087788504

Locations
China, Beijing
radiation department, Cancer Hospital, CAMS Recruiting
Beijing, Beijing, China, 100021
Contact: Yu Tang     08601087788122     tangyu.pumc@gmail.com    
Contact: Wenyang Liu, Ph.D.     08601087788504        
Principal Investigator: Jing Jin, Ph.D.            
Principal Investigator: Yexiong Li, Ph.D.            
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Jing Jin, Ph.D. Chinese Academic Medical Science
Principal Investigator: Yexiong Li, Ph.D. Chinese Academic Medical Science
  More Information

Publications:

Responsible Party: Jing Jin, M.D., vice chair of radiation department, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01584544     History of Changes
Other Study ID Numbers: CH-GI-024
Study First Received: April 20, 2012
Last Updated: May 28, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:
rectal neoplasms
aged
chemoradiotherapy
clinical trials, phase I
capecitabine

Additional relevant MeSH terms:
Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
 Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013