The Effect of Preoperative Docetaxel, Cisplatin and Capecitabine on Serum RUNX3 Hypermethylation Status in Patients With Gastric and Lower Oesophagus Adenocarcinoma

NCT00674167 | Unknown Phase 2 DMC

• 3 other identifiers: GA02/33/062006/00462CTC0700084
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

• To assess the radiological response, curative resection rate of preoperative docetaxel/cisplatin/capecitabine(DCX).
• To correlate treatment response with serum RUNX3 promoter hypermethylation.
• To determine the toxicities of preoperative DCX
• To determine the time to progression/overall survival of preoperative DCX

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of Response and Progression using RECIST Criteria

  Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques (CT, MRI, x-ray) or as \>10 mm with spiral CT scan.

  baseline and after two cycles of chemotherapy

Secondary Outcomes (1)

• Detection of methylated and unmethylated DNA

  before and after pre-operative chemotherapy (6-8 weeks)

Study Arms (3)

Docetaxel

EXPERIMENTAL

Three cycles of chemotherapy will be administered before surgery with docetaxel and cisplatin at 30 mg/m² on day 1 and 8 in a 21 day treatment cycles.

Drug: Docetaxel

Cisplatin

EXPERIMENTAL

Three cycles of chemotherapy will be administered before surgery with cisplatin at 30 mg/m² on day 1 and 8 in a 21 day treatment cycle.

Drug: Cisplatin

Capecitabine

EXPERIMENTAL

Three cycles of chemotherapy will be administered before surgery with capecitabine at 750 mg/m² twice daily from day 1 to 14 in a 21 day treatment cycles.

Drug: Capecitabine

Interventions

Docetaxel DRUG

Three cycles of chemotherapy will be administered before surgery with docetaxel at 30 mg/m² on day 1 and 8 in a 21 day treatment cycles.

Docetaxel

Cisplatin DRUG

Three cycles of chemotherapy will be administered before surgery with cisplatin at 30 mg/m² on day 1 and 8 in a 21 day treatment cycle.

Cisplatin

Capecitabine DRUG

Three cycles of chemotherapy will be administered before surgery with capecitabine at 750 mg/m² twice daily from day 1 to 14 in a 21 day treatment cycle.

Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or lower third of the oesophagusthat considered to be stage II (through the submucosa) or higher, with no evidence of distant metastases, or locally advanced inoperable disease, as evaluated by computed tomography, chest radiography, ultrasonography, or laparoscopy.
• Patients must have evaluable or measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan.
• Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of DCX in patients \<18 years of age, children are excluded from this study.
• ECOG performance status \<= 1 (see Appendix A).
• Patients must have normal organ and marrow function as defined below:
• X leukocytes \>= 3,000/mcL X absolute neutrophil count \>= 1,500/mcL X platelets \>= 100,000/mcL X total bilirubin within normal institutional limits X AST(SGOT)/ALT(SGPT) \<= 2.5 X institutional upper limit of normal X creatinine within normal institutional limits
• The effects of DCX on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Patients who have had prior chemotherapy or radiotherapy.
• Patients may not be receiving any other investigational agents.
• Patients with stage I or IV cancer of the stomach or lower oesophagus.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetacel, cisplatin or capecitabine.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because agents use in the study may cause fetal harm.
• HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with docetaxel. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

Related Publications (2)

• Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.

  PMID: 16822992 BACKGROUND

• Cassidy J, Twelves C, Van Cutsem E, Hoff P, Bajetta E, Boyer M, Bugat R, Burger U, Garin A, Graeven U, McKendric J, Maroun J, Marshall J, Osterwalder B, Perez-Manga G, Rosso R, Rougier P, Schilsky RL; Capecitabine Colorectal Cancer Study Group. First-line oral capecitabine therapy in metastatic colorectal cancer: a favorable safety profile compared with intravenous 5-fluorouracil/leucovorin. Ann Oncol. 2002 Apr;13(4):566-75. doi: 10.1093/annonc/mdf089.

  PMID: 12056707 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel; Cisplatin; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Wei Peng Yong, MRCP, MB ChB

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Yong Wei Peng

Study Record Dates

• First Submitted: May 5, 2008
• First Posted: May 7, 2008
• Study Start: May 1, 2007
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2017
• Last Updated: June 12, 2015

Record last verified: 2015-06

Locations

SG (1)