PP-Gemcitabine & External Beam Radiation-Sarcomas

Sarcoma Clinical Trial

Official title:

A Phase I Study of Preoperative Concomitant Gemcitabine and External-Beam Radiation Therapy and Surgical Resection for Patients With Extremity and Trunk Soft Tissue Sarcomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046304
• Other study ID #: ID01-532
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2014
• Last updated: April 4, 2016
• Start date: December 2001
• Est. completion date: March 2015

Study information

• Verified date: April 2016
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Before the start of treatment, participants will have a physical exam, blood tests, a MRI scan, and a chest x-ray. A PET scan may be done if thought necessary.

Participants will receive the drug gemcitabine by vein along with radiation therapy on Days 1, 8, 22, 29, 43, and 50. Radiation treatments will be given 5 days a week for 5 weeks. The gemcitabine and radiotherapy will be given on an outpatient basis. Chemotherapy and/or radiotherapy may be stopped if side effects become severe.

About 4 to 6 weeks after the final dose of gemcitabine, surgery will be done to remove the tumor or to remove any previous surgical scar and leftover tumor.

During the combined treatment, participants will be seen weekly by the doctor in charge of radiotherapy or by the study nurse. Blood tests will be done every week during treatment. A MRI scan and a chest x-ray will be done within 14 days before surgery. A PET scan will be done if thought necessary.

After the surgery is done, participants will return to M. D. Anderson for follow-up visits every 4 months for the first 2 years, every 6 months for 3 years, and then yearly from then on. An ultrasound and MRI scan (of the extremity or trunk) will be done 3 months after completion of all treatment. Ultrasound scans will be performed at each visit. A MRI scan will only be done again at later visits if needed.

This is an investigational study. Gemcitabine is approved for use by the FDA. Its use together with radiation therapy in this study is experimental. About 36 individuals will take part in the study. All will be enrolled at M. D. Anderson.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma

Intervention

Drug:
• Gemcitabine
Starting dose: 400 mg/m2 by vein on days 1, 8, 22, 29, 43, and 50.

Radiation:
• Radiation Therapy
Radiation therapy dose of 50 Gy in 25 fractions at 2.0 Gy per fraction. Radiotherapy given once daily (Monday through Friday) for 5 weeks.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose of Preoperative Gemcitabine with External-Beam Radiation Therapy	The maximum tolerated dose (MTD) defined as the dose having posterior expected toxicity importance score (TIS) closest to the target 1.65 at the end of the trial.	6 weeks	No
Secondary	Response to Preoperative Gemcitabine with External-Beam Radiation Therapy	Response to preoperative chemoradiotherapy measured by comparing pre- and post-treatment MRI scans using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Evaluation of the MRI-defined change used to measure radiographic response.	3 months after completion of all treatment	No

External Links

•   University of Texas MD Anderson Cancer Center Website