NCT00142571

Brief Summary

The purpose of this study is to compare the drug gemcitabine to two drugs, gemcitabine and docetaxel, to find out which treatment is better for people with sarcomas.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

October 2, 2007

Status Verified

October 1, 2007

First QC Date

August 31, 2005

Last Update Submit

October 1, 2007

Conditions

Sarcoma, Soft Tissue

Keywords

Sarcoma, Soft TissueGemcitabineDocetaxel

Outcome Measures

Primary Outcomes (1)

  • Determine whether the failure rate (defined as progression or death) among patients with unresectable soft tissue sarcoma is improved with gemcitabine plus docetaxel compared with gemcitabine alone

Secondary Outcomes (4)

  • Determine whether the failure rate (defined as progression or death) at 3 and 6 months is improved among patients with unresectable soft tissue sarcoma treated with gemcitabine plus docetaxel compared with those treated with gemcitabine alone.

  • Overall survival will be evaluated

  • Response rate will be evaluated

  • Toxicity will be evaluated

Interventions

GemcitabineDRUG
DocetaxelDRUG

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven soft tissue sarcoma (except the following histologies: gastrointestinal stromal tumors (GIST), Kaposi's Sarcoma, mesotheliomas
  • Age \>= 10 years
  • Recurrent or progressive disease defined as an increase in size of any existing tumor mass, or the development of new tumor mass or masses, which is not amenable to definitive surgical therapy.
  • Patients may have had another cancer but there must be convincing clinical evidence that the sarcoma is the disease requiring therapeutic intervention. (ie. Several sarcoma patients have had had a prior cancer (Hodgkin's disease or breast cancer) treated years previously and then developed a clinically active sarcoma.)
  • Patients may have failed no more than 3 prior chemotherapy regimens.
  • Measurable disease as defined by RECIST. Measurable disease is the presence of at least one measurable lesion. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. A measurable lesion is one that can be accurately measured in at least one dimension with longest diameter \>20 mm using conventional techniques or \>10 mm with spiral CT scan.
  • Karnofsky performance status of greater than or equal to 60%
  • Peripheral neuropathy, if present, must be \< or = to grade 1
  • At least 3 weeks since prior chemotherapy (10 days if the patient was on imatinib, thalidomide, or an interferon)
  • At least 3 weeks since prior radiation therapy
  • Absolute neutrophil count \> 1,500/mm3
  • Hemoglobin \> 8.0 g/dl
  • Platelet count \> 100,000/mm3
  • Total Bilirubin \< upper limit of normal (ULN).
  • ALT (SGOT) or AST (SGPT) \<5 x ULN.
  • +5 more criteria

You may not qualify if:

  • Soft tissue sarcomas with the following histologies: gastrointestinal stromal tumors (GIST), Kaposi's sarcoma, mesotheliomas
  • Active or uncontrolled infection (on antibiotic therapy for acute or chronic infection)
  • Prior treatment with gemcitabine or docetaxel
  • Peripheral neuropathy \> or = grade 2
  • History of known hypersensitivity reaction to agents formulated in polysorbate 80, the solubilizing agent for docetaxel \[e.g. interferon alpha-2a, children's ibuprofen suspension (Advil), terconazole (Terazol), lamivudine (Epivir), etoposide, amiodarone, vaccines (DtaP, influenza), bupropion (Wellbutrin), Vitamins B12, C+zinc+selenium\].
  • Uncontrolled, central nervous system metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

MeSH Terms

Conditions

Sarcoma

Interventions

GemcitabineDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Robert Maki, MD, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

January 1, 2003

Study Completion

September 1, 2007

Last Updated

October 2, 2007

Record last verified: 2007-10

Locations

US(1)