Using Genetic Polymorphisms to Predict the Efficacy and Toxicity - A Gastric Adenocarcinoma Study

NCT01558011 | Terminated Phase 2 DMC

• 2 other identifiers: T3211100CT202
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, non-comparative phase II study of sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.

Conditions

Gastric Adenocarcinoma

Keywords

gastric adenocarcinoma; Capecitabine and oxaliplatin (XELOX); Docetaxel and capecitabine (TX); Using genetic polymorphisms; drug metabolism and immunohistochemical stain; predict the efficacy

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Tumor responses in measurable lesions are to be evaluated by the tumor response guidelines validated by the Response Evaluation Criteria in Solid Tumors (RECIST) Group . The new version 1.1 was published in 2009.

  Every 6 weeks

Secondary Outcomes (1)

• Progression-free survival

  Every 6 weeks

Study Arms (1)

chemotherapy

EXPERIMENTAL

Chemotherapy: Drug: Capecitabine, Oxaliplatin, Docetaxel Dosing Regimena: total of 6 cycles of modified XELOX regimen repeats every 2 weeks, and followed by 4 cycles of TX repeats every 3 weeks. After 10 cycles of treatment, patients may continue to treat with either of the regimen, preferably the one having the best efficacy.

Drug: Capecitabine, Oxaliplatin, Docetaxel

Interventions

Capecitabine, Oxaliplatin, Docetaxel DRUG

Capecitabine: 500 mg film coated tablets; Oxaliplatin: 50 mg/ 10 ml; Docetaxel: 20 mg / 0.5ml vial. Dosing Regimena: total of 6 cycles of modified XELOX regimen repeats every 2 weeks, and followed by 4 cycles of TX repeats every 3 weeks. After 10 cycles of treatment, patients may continue to treat with either of the regimen, preferably the one having the best efficacy.

Also known as: Capecitabine (Xeloda○R), company: Roche, Oxaliplatin (Eloxatin○R, company: Sanofi-Avantis, Docetaxel (Taxotere○R, company: Sanofi-Avantis

chemotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed gastric adenocarcinoma.
• At least one measurable lesion in a non-irradiated area.
• No prior exposure to systemic chemotherapy for advanced gastric cancer.
• For those have adjuvant chemotherapy after a curative gastrectomy, the last dosing of previous adjuvant chemotherapy should be at least 6 months before the start of this treatment.
• Age \> 20 years old.
• ECOG Performance Status 2.
• Life expectancy greater than 12 weeks.
• Adequate bone marrow function :absolutely neutrophil count 1.5 x 109/L or WBC 4 x 109/L; Hemoglobin \> 9 g/dl;platelet count 100 x 109/L.
• Adequate liver function : ALT \& AST 2.5 x ULN if without liver metastasis or 5 x ULN if with hepatic metastasis. Alkaline phosphatase 2.5 x ULN if without liver metastasis or 5 x ULN, if with hepatic and bone metastasis. Bilirubin \< 2 x ULN
• Adequate renal function :Creatinine \< 1.5 x ULN.
• Patients must be accessible for treatment and follow-up in the participating centers.

You may not qualify if:

• Patient who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy.(Previous radiotherapy is allowable if the last dose was given more than 2 weeks before the protocol treatment).
• Major surgery within two weeks prior to entering the study.
• Patients with CNS metastasis, including clinical suspicion.
• Patients who are under active or uncontrolled infections.
• Patients who had cardiac arrhythmia or myocardial infarction history 6 months before entry.
• Patients with clinically detectable peripheral neuropathy \> 2 on the CTC criteria
• Patients with concomitant illness that might be aggravated by chemotherapy.
• Patients who are pregnant or with breast feeding.
• Other concomitant or previously malignancy within 5 yrs except for in situ cervix cancer or squamous cell carcinoma of the skin treated by surgery only.
• Patients with hypersensitivity to any component of the chemotherapeutic regimen.
• Mental status is not fit for clinical trial
• Can not take study medication orally

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• Taipei Veterans General Hospital, Taiwan: collaborator
• Tri-Service General Hospital: collaborator
• Mackay Memorial Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator

Study Sites (1)

National Health Research Institutes

Zhunan, Miaoli, 350, Taiwan

Location

MeSH Terms

Interventions

Capecitabine; Oxaliplatin; Docetaxel

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2012
• First Posted: March 20, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2015
• Last Updated: May 4, 2016

Record last verified: 2013-10

Locations

TW (1)