Docetaxel and Epirubicin in Advanced Gastric Cancer

NCT00375999 | Completed Phase 2 Results

• 1 other identifier: 2004-232
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

1.Study rationale:There is no standard regimen for the advanced and/or metastatic gastric cancer patients who relapsed after adjuvant chemotherapy or failed to first systemic chemotherapy. 2.Primary Objectives:To evaluate overall response rate according to the Response Evaluation Criteria in Solid Tumors criteria and To investigate time to response 3.Design:single-center, Open label, Phase II study. docetaxel 75mg/m2 administered on day 1 as intravenously combined with intravenous Epirubicin 60mg/m2 given day 2 every 3 weeks. 4.Primary endpoints:

1. 1.Efficacy:overall response rate according to the Response Evaluation Criteria in Solid Tumors criteria, time to response, duration of response, and time to treatment failure.
2. 2.Safety-Adverse events and laboratory tests, graded according to the NCI Common Toxicity Criteria for Adverse Effects (version 3.0).

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  One year

Study Arms (1)

docetaxel and epirubicin

EXPERIMENTAL

salvage docetaxel and epirubicin

Drug: Docetaxel and epirubicin

Interventions

Docetaxel and epirubicin DRUG

Also known as: taxotere, pharmorubicin

docetaxel and epirubicin

Eligibility Criteria

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

You may qualify if:

• Male and female outpatients ≥ 18 years,
• Eastern Cooperative Oncology Group performance status below 1, with histologically confirmed as gastric adenocarcinoma with inoperable and/or metastatic disease.
• Patients must have at least one target lesion with a minimum lesion size as per the Response Evaluation Criteria in Solid Tumors criteria (at least 1 unidimensional measurable lesion ≥ 20 mm in diameter by conventional CT or MRI scan, or ≥ 10 mm in diameter by spiral CT scan).
• Creatinine clearance ≥ 60ml/min (estimated creatinine clearance must be calculated at baseline for all patients.)
• Adequate major organ function : - Hematopoietic function: white blood cell \>4,000/mm3 or absolute neutrophil count \> 2,000/mm3, Platelet count ≥ 100,000/mm3,- Hepatic function: Bilirubin \< 1.5 X upper normal limit, aspartate aminotransferase/alanine aminotransferase levels \<2.5 X upper normal limit, alkaline phosphatase \< 5 x upper normal limit (except in case of bone metastasis without any liver disease) - Renal function: Creatinine \<1 x upper normal limit or creatinine clearance ≥ 60ml/min.

You may not qualify if:

• Patients must not have previously received systemic treatment (cytotoxic chemotherapy or active/passive immunotherapy) for advanced or metastatic disease.
• Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment.
• The following laboratory values: - neutrophils ≤1.5 X 109 /L, platelet count\<100 X 109 /L- serum bilirubin ≥ 1.5 X upper normal limit, aspartate aminotransferase
• , alanine aminotransferase \> 2.5 X upper normal limit or \> 5 X upper normal limit in the case of liver metastases- Alkaline phosphatase \> 2.5 X upper normal limit or 5 X upper normal limit in the case of liver metastases or \> 10 X upper normal limit in the case of bone disease.
• Prior therapy with Taxotere or Epirubicin is excluded.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yongdong Severance Hospital

Seoul, South Korea

Location

Related Publications (1)

• Lim JY, Cho JY, Paik YH, Lee DK, Lee SI, Park HJ, Lee SJ, Lee KS, Yoon DS, Choi SH. Salvage chemotherapy with docetaxel and epirubicin for advanced/metastatic gastric cancer. Oncology. 2007;73(1-2):2-8. doi: 10.1159/000120027. Epub 2008 Mar 10.

  PMID: 18332648 RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel; Epirubicin

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; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Dr. Jae Yong Cho
• Organization: Gangnam Severance Hospital, Yonsei University College of Medicine

chojy@yuhs.ac

82-2-2019-4363

Study Officials

• Jae Yong Cho

  Yonsei University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chisf of Medical oncology, Gangnam Severance Hospital

Study Record Dates

• First Submitted: September 13, 2006
• First Posted: September 14, 2006
• Study Start: September 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: March 3, 2014
• Results First Posted: March 3, 2014

Record last verified: 2014-01

Locations

KR (1)