Study on VCD/IE in the Patients With Ewing's Sarcoma Family of Tumors (ESFT)

This study has been terminated.
(The enrollment is slower than expected)
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00568464
First received: December 5, 2007
Last updated: July 6, 2009
Last verified: July 2009
  Purpose

The purpose of this clinical trial was to evaluate the efficacy and tolerability of the sequential therapy of VCD/IE in the patients with ESFT.


Condition Intervention Phase
Ewing's Sarcoma
Drug: VCR, CTX, ADM; IFO, VP-16
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of VCD/IE in the Treatment of the Patients With Ewing's Sarcoma Family of Tumors

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Response Rate [ Time Frame: every two cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: March 2007
Estimated Study Completion Date: September 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: VCR, CTX, ADM; IFO, VP-16
VCD: VCR 2 mg d1, CTX 1200 mg/m2 d1, Mesna 240 mg/m2 tid d1, ADM 75mg/m2 d1, G-CSF 300 ug/d d5-11; IE: IFO 1800mg/m2 d1-5,Mesna 360 mg/m2 tid d1-5,VP-16 100 mg/m2 d1-5,G-CSF 300 ug/d d6-12; q3w. Surgery or radiation will be done to the patients with local diseases after four cycles of VCD/IE.
Other Name: VCD/IE

Detailed Description:

80-90% patients of ESFT will develope disease progression during the period of local treatment (surgery or radiation). The survival has been improved in these 30 years due to chemotherapy. VCD/IE is widely used in the world for the patients with ESFT, but it is rarely used in China due to its high dosage.

  Eligibility

Ages Eligible for Study:   10 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age range 10-65 years old
  • Histological confirmed ESFT
  • No previous therapy
  • ECOG performance status less than 2
  • Life expectancy of more than 12 weeks
  • Normal laboratory values: hemoglobin>8.0g/dl, neutrophil>2×109/L, platelet > 80×109/L, Hb > 80×1012/L, serum creatine < 1×upper limitation of normal(ULN), serum bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN

Exclusion Criteria:

  • Pregnant or lactating women
  • Received treatment for the disease previously
  • Serious uncontrolled diseases and intercurrent infection
  • The evidence of CNS metastasis and bone marrow involvement
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • History of allergy to the drugs in this trial
  • Abnormal LVEF level
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568464

Locations
China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Ye Guo, M.D. Fudan University
  More Information

No publications provided

Responsible Party: Base for drug clinical trials, Fudan University cancer hospital, Fudan University cancer hospital
ClinicalTrials.gov Identifier: NCT00568464     History of Changes
Other Study ID Numbers: VCD/IE-ESFT
Study First Received: December 5, 2007
Last Updated: July 6, 2009
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
ESFT (Ewing's sarcoma family of tumors)
Response rate
TTP
OS
Toxicity

Additional relevant MeSH terms:
Sarcoma, Ewing
Sarcoma
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 21, 2014