PP-Gemcitabine & External Beam Radiation-Sarcomas

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to find the highest safe dose of gemcitabine that can be given with radiotherapy before surgery to treat sarcoma. This study will also look at how well this treatment controls sarcoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Eli Lilly and Company
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

1. Patients with cytologic or histologic proof of Grade II or III resectable soft tissue sarcoma of the extremity or trunk.

2. Patients with both measurable and non-measurable disease. Patients who are S/P pre-referral excision will be eligible.

3. Inclusion of patients with a prior history of malignancy will be at the discretion of the Study Chairman.

4. Patients must have a Zubrod Point Scale of 0 or 1.

5. Absolute neutrophil count must be > 1,500 cells/mm; platelet count greater than or equal to 100,000 platelets/ml; serum creatinine less than or equal to 1.8 mg/dl, serum glutamate oxaloacetate transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) less than or equal to 3 x normal, total bilirubin less then or equal to 1.5 mg/dl.

6. Patients must have no uncontrolled coexisting medical conditions.

7. Women of childbearing potential must not be pregnant or breast feeding and must practice adequate contraception.

8. All patients must sign an informed consent.

Exclusion Criteria:

1) Patients with a history of prior radiotherapy in the area of the primary tumor or those in whom the anticipated radiation field would include the perineum, scrotum, or vaginal introitus will not be eligible.