PP-Gemcitabine & External Beam Radiation-Sarcomas

NCT ID: NCT02046304

Last Updated: 2016-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-12-31
• Study Completion Date: 2015-03-31

Brief 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.

Detailed 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.

Conditions

Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine + Radiation Therapy

Patients receive concurrent chemoradiation (days 1 - 33) consisting of external beam radiotherapy (EBRT) plus gemcitabine, administered in a phase I dose escalation format until MTD is reached. EBRT delivered preoperatively (for patients with measurable disease) or postoperatively (for patients who have undergone pre-referral excisional biopsy) to a dose of 50 Gy in 25 fractions at 2.0 Gy per fraction. Radiotherapy given once daily (Monday through Friday) for 5 weeks. Surgical resection of the post-treatment tumor mass performed 4 to 8 weeks after the final dose of gemcitabine. Gemcitabine administered intravenously (IV) on days 1, 8, 22, 29, 43, and 50, concurrently with radiotherapy. Starting dose of gemcitabine 400 mg/m2 by vein once a week.

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

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

Radiation Therapy

Intervention Type: RADIATION

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.

Interventions

Gemcitabine

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

Intervention Type: DRUG

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.

Intervention Type: RADIATION

Other Intervention Names

Gemcitabine Hydrochloride; Gemzar; XRT; EBRT; Radiotherapy

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter W. Pisters, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

ID01-532

Identifier Type: -

Identifier Source: org_study_id