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

NCT00568464 | Terminated Phase 2

• 1 other identifier: VCD/IE-ESFT
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ewing's Sarcoma

Keywords

ESFT (Ewing's sarcoma family of tumors); Response rate; TTP; OS; Toxicity

Outcome Measures

Primary Outcomes (1)

• Response Rate

  every two cycles

Secondary Outcomes (1)

• Toxicity

  every cycle

Study Arms (1)

A

EXPERIMENTAL

Drug: VCR, CTX, ADM; IFO, VP-16

Interventions

VCR, CTX, ADM; IFO, VP-16 DRUG

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.

Also known as: VCD/IE

A

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Sarcoma, Ewing

Interventions

Etoposide

Condition Hierarchy (Ancestors)

Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Ye Guo, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 6, 2007
• Study Start: March 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 7, 2009

Record last verified: 2009-07

Locations

CN (1)