http://clinicaltrials.mayo.edu/clinicaltrialdetails.cfm?trial_id=100300

The Use of Chemotherapy Medications, Gemcitabine (Gemzar) and Docetaxel
(Taxotere) in the Treatment of Ewing's Sarcoma, Osteosarcoma, or
Chondrosarcoma

IRB Number : 1693-05

Trial Status : Open for Enrollment

Phase: II

Why is this study being done?
This study is being done to:
-See if the chemotherapy drugs gemcitabine (Gemzar) and docetaxel
(Taxotere), when given together, may help to fight cancer of the bone or
soft tissue. Each of these drugs is approved by the US Food and Drug
Administration (FDA) for the treatment of some kinds of cancer, such as
cancer of the pancreas and lung, but they are not approved for this type
of cancer, so in this study they are called investigational drugs.
-See what effects (good and bad) gemcitabine and docetaxel have on the
patient and the tumor.
-See how a patients body processes the gemcitabine and docetaxel.
-(When possible), to do genetic research studies on a sample of a
patients tumor tissue.

Who is Eligible to Participate in the Study?
-Patients diagnosed with Ewings sarcoma or Osteosarcoma, and have
received standard treatments for this type of cancer, but the tumor has
come back after treatment.
-Patients diagnosed with chondrosarcoma and the tumor cannot be
completely removed by surgery or has come back after surgery.
- Patients age 4 and older
-No prior treatment with gemcitabine or taxanes

*More specific, detailed eligibility and/ or exclusion criteria are
associated with this trial.

What is Involved With this Study?
-Medication given through a vein 2 times in a 3 week cycle, for up to 14
cycles
-Physical Exams
-Weekly Blood Tests
-X-rays, CT scans, MRI scans and/ or nuclear medicine scans including a
bone scan to measure patients tumor

How long will the Study run?
Patients will be in the study and receive treatment as long as the tumor
has stayed the same or has gotten smaller and patient has not had any
bad side effects, for up to 14 cycles (each cycle is 3 weeks). Treatment
will be stopped if patients tumor gets larger, if bad side effects, if
doctor thinks further treatment would not be in patients best interest,
if study closes, or if patient chooses to stop treatment.

Sponsor(s): MD Anderson Cancer Center

Study Activation: 12-19-2005

IRB Review and Approval Date: 9-8-2005

Study Type: Treatment

Projected Accrual: 10 patients

Costs of Study:There may be standard patient care costs related to
participating in a cancer research study.

Principal Investigator: Dr. Scott Okuno

Who can I Contact for Additional Information on this Trial?
If you are interested in participating in this study or would like
additional information, please contact Mayo Clinic's Cancer Center
Clinical Trials Referral Coordinator at (507) 538-7623.

What is/are the Locations of this Clinical Trial?
Rochester, MN