Dr. Elizabeth Fox, Staff Clinician, Pharmacology & Experimental Therapeutics Section, Pediatric Oncology Branch, Center for Cancer Research, NCI, is the Principal Investigator for this clinical trial.  The clinical trial is open to accrual for patients with Ewings sarcoma or chondrosarcoma at 18 sites across the United States.

Trial Background

Ewing’s sarcoma, osteosarcoma, and chondrosarcoma are relatively common malignancies in adolescents and young adults.  Advances in surgical and chemotherapeutic approaches to these malignancies have significantly improved the outcome for some patients.  However, these advances have not improved survival of patients who have metastatic, recurrent or unresectable disease.  The purpose of this study is to determine if chemotherapy with gemcitabine and docetaxel can decrease the size of tumors in patients with these types of cancer.  In the laboratory, treatment of cells from tumors including lung cancer, breast cancer, and osteosarcoma with gemcitabine followed by docetaxel resulted in increased killing of tumor cells compared to treatment with both drugs at the same time or treatment with docetaxel followed by gemcitabine.  In women with advanced leiomyosarcoma of the uterus, the combination of gemcitabine followed by docetaxel resulted in tumor shrinkage in half of the women treated in an early clinical trial and a trial of gemcitabine, docetaxel and doxorubicin is currently being conducted (SARC 005).

 

Trial

In this trial, gemcitabine is administered by intravenous infusion on day 1 and day 8, and docetaxel is administered intravenously on day 8 of each chemotherapy cycle.  White cell growth factors (filgrastim or peg-filgrastim) will be administered beginning on day 9 of each cycle.  Each cycle is 21 days. Prior to enrolling on the clinical trial and periodically throughout the trial imaging studies (X-ray, CAT scans, MRI scan, or bone scans) and blood work will be done to monitor  side effects and the effect of gemcitabine and docetaxel on the tumor. There is no limit on the number of chemotherapy cycles that can be administered as long as no serious side effects occur and the tumor is not increasing in size. 

In addition, investigators on this trial are studying the pharmacokinetics of (how the body handles) gemcitabine and docetaxel. Participating in the pharmacokinetics is voluntary and patients can elect not to have blood drawn for pharmacokinetics and still receive gemcitabine and docetaxel on this trial.

The clinical trial opened to accrual in May 2006.  Accrual is currently open for patients with Ewings sarcoma and chondrosarcoma.  Accrual for patients with osteosarcoma is closed.

Participation in the trial*

To be eligible to participate in this trial an individual must:

·  Have a confirmed diagnosis of recurrent, refractory (did not respond to initial chemotherapy) Ewings sarcoma or unresectable or recurrent chondrosarcoma.

·  Be older than 4 years of age

·  Be active, able to perform light physical activity (such as light house work, office work or school work)

·  Have acceptable function of kidneys, bone marrow and liver, which can be determined from blood tests

 

Individuals are NOT able to participate in this study if they have:

·  Received more than 2 prior chemotherapy regimens (regimens of chemotherapy consist of single or combinations of chemotherapy, please contact us if you are not sure how many chemotherapy regimens  have been administered previously).

·  Received radiation therapy in the prior 6 weeks

·  Have previously received gemcitabine (Gemzar™) or docetaxel (Taxotere™)

·  Have previously received a transplant using bone marrow or stem cells from another individual

·  Currently have an uncontrolled infection

 

*This represents a partial list of safety requirements to participate in the clinical trial.  A complete list is available from SARC or Dr. Fox.

 

For more information contact SARC at 734.930.7600 or Dr. Fox at 301.402.6641

 

This trial is registered at clinicaltrials .gov  (NCT00073983)

 

Full title: SARC (Sarcoma Alliance for Research through Collaboration) Study:  Phase II Study of Sequential Gemcitabine Followed by Docetaxel for Recurrent Ewing’s Sarcoma, Osteosarcoma, or Unresectable or Locally Recurrent Chondrosarcoma

 

Glossary:

·  Gemcitabine (brand name Gemzar™)

·  Docetaxel (brand name Taxotere™)

·  Pharmacokinetics- a series of blood samples from individuals to determine  the concentration of the drug in each sample to measure how the body handles (distributes to tissues, metabolizes and eliminates)  a drug over time.