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Phase I/II Trial of Neoadjuvant Conformal Radiotherapy Plus Sorafenib for Patients With Soft Tissue Sarcoma of the Extremity and Body Wall


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Sarcoma

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Trial Information

Phase I/II Trial of Neoadjuvant Conformal Radiotherapy Plus Sorafenib for Patients With Soft Tissue Sarcoma of the Extremity and Body Wall


OBJECTIVES:

Primary

- To determine the maximum tolerated dose of sorafenib tosylate when combined with
conformal external beam radiotherapy prior to resection with curative intent in
patients with soft tissue sarcoma of the extremity or body wall. (Phase I)

- To determine the rate of near-complete (≥ 95% tumor necrosis) pathological response to
this regimen in these patients. (Phase II)

Secondary

- To describe the toxicities associated with this regimen.

- To determine the rate of R0 (negative resection margin), R1 (microscopically positive
resection margin), and R2 (macroscopically positive resection margin) following this
regimen.

- To determine the radiographic response rate to this regimen as defined by conventional
RECIST criteria.

- To obtain preliminary data regarding local disease control, distant disease control,
progression-free survival, and overall survival with this regimen.

OUTLINE: This is a phase I dose-escalation study of sorafenib tosylate followed by a phase
II study.

Patients receive oral sorafenib tosylate twice daily on days 1-35 and undergo conformal
radiotherapy 5 days a week for 5 weeks.

Patients undergo dynamic contrast-enhanced MRI scanning at baseline and day 63 followed by
surgical resection on day 70.

After completion of study therapy, patients are followed every 4 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed soft tissue sarcoma located on the extremity or body wall
and meeting 1 of the following criteria:

- Intermediate- or high-grade disease > 5 cm in maximal dimension

- Low-grade disease > 8 cm in maximal dimension

- No evidence of regional or distant metastatic disease

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Hemoglobin ≥ 9.0 g/dL

- ANC ≥ 1,500/mm^3

- Platelets ≥ 100,000/mm^3

- Total bilirubin ≤ 1.5 mg/dL (unless elevated due to Gilbert's syndrome)

- AST and ALT ≤ 2.5 times upper limit of normal (ULN)

- Creatinine ≤ 1.5 times ULN

- INR < 1.5 or PT/PTT within normal limits

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception (men must use effective
contraception for ≥ 3 months after completion of study treatment)

- Able to swallow whole pills

- None of the following cardiac conditions:

- NYHA class III-IV congestive heart failure

- Unstable angina (i.e., anginal symptoms at rest)

- New-onset angina (beginning within the past 3 months)

- Myocardial infarction within the past 6 months

- History of cardiac ventricular arrhythmia requiring ongoing anti-arrhythmic
therapy

- Uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP >
90 mm Hg, despite optimal medical management

- No prior clinical or laboratory evidence of bleeding diathesis or coagulopathy

- No thrombotic or embolic events (e.g., cerebrovascular accident including transient
ischemic attacks) within the past 6 months

- No pulmonary hemorrhage or bleeding event ≥ CTCAE grade 2 within the past 4 weeks

- No other hemorrhage or bleeding event ≥ CTCAE grade 3 within the past 4 weeks

- No significant traumatic injury in the past 4 weeks

- No active malabsorption problem not controlled with medical therapy

- No active clinically serious infection > CTCAE grade 2

- No known HIV infection or chronic hepatitis B or C

- No known or suspected allergy to sorafenib tosylate or any agent given in this study

- No indwelling metal that would preclude patient from undergoing DCE-MRI

PRIOR CONCURRENT THERAPY:

- At least 4 weeks since prior major surgery

- No prior or other concurrent preoperative investigational treatment

- No other concurrent cancer-directed therapy

- No concurrent St. John's wort or rifampin

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximal-tolerated dose of sorafenib tosylate when combined with conformal radiotherapy (Phase I)

Principal Investigator

Robert Canter, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Davis

Authority:

Unspecified

Study ID:

CDR0000628781

NCT ID:

NCT00805727

Start Date:

May 2009

Completion Date:

Related Keywords:

  • Sarcoma
  • stage I adult soft tissue sarcoma
  • stage II adult soft tissue sarcoma
  • stage III adult soft tissue sarcoma
  • Sarcoma

Name

Location

University of California Davis Cancer CenterSacramento, California  95817