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Radiation Therapy With or Without SU5416 in Treating Patients With Soft Tissue Sarcoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00023725
First received: September 13, 2001
Last updated: February 6, 2009
Last verified: August 2007
History of Changes
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as SU5416 may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if radiation therapy is more effective with or without SU5416 in treating soft tissue sarcoma.

PURPOSE: Phase I/II trial to compare the effectiveness of radiation therapy with or without SU5416 in treating patients who have stage IB or stage IIA soft tissue sarcoma.


Condition Intervention Phase
Sarcoma
 Drug: semaxanib
Procedure: conventional surgery
Radiation: radiation therapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Phase I/II Study Of Preoperative Radiotherapy With/Without SUGEN 5416 (NSC # 696819; A TK Inhibitor Anti-Angiogenesis Compound) In The Management Of Low To Intermediate Grade Soft Tissue Sarcoma Of The Trunk or Extremity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2001
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of SU5416 when combined with neoadjuvant radiotherapy in patients with stage IB or IIA soft tissue sarcoma.
  • Determine the antiangiogenic effects of SU5416 in these patients.
  • Determine any synergistic antiangiogenic effect of SU5416 with radiotherapy in these patients.
  • Compare the disease-free survival, local recurrence, distant metastases, and overall survival rates in patients treated with neoadjuvant radiotherapy with or without SU5416.

OUTLINE: This is a phase I dose-escalation study of SU5416 followed by a phase II randomized study.

Phase I:

  • Patients undergo radiotherapy once daily, 5 days a week, for 5 weeks. Patients also receive SU5416 IV over 1 hour twice weekly beginning on week 1 and continuing until 2 days before surgery.
  • Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Phase II:

  • Once the MTD has been determined, additional patients are accrued and then randomized to receive either treatment as in phase I at the MTD vs preoperative radiotherapy alone.

All patients undergo surgical resection 70-80 days after beginning therapy. Patients with positive surgical margins receive additional radiotherapy daily for 8 days and SU5416 IV over 1 hour on days 2, 4, and 9.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 18 patients will be accrued for phase I of this study within 1 year. Approximately 28 patients will be accrued for phase II of this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary or locally recurrent stage IB or IIA soft tissue sarcoma

    • Grade 1 or 2
    • Tumor greater than 5 cm in diameter
  • Tumor located on upper extremities (including shoulder), lower extremities (including hip), or body wall
  • No sarcoma of the head and neck or intra-abdominal or retroperitoneal sarcoma
  • No desmoid tumor or dermatofibrosarcoma protuberans
  • No metastatic disease

  • No evidence of lung metastases

    • Maximum of 4 lung lesions no greater than 5 mm in diameter each on preoperative chest CT scan allowed OR
    • Lesion no greater than 1 cm allowed if stable for at least 1 year and fits criteria for granuloma

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-1

Life expectancy:

  • At least 2 years

Hematopoietic:

  • WBC at least 4,000/mm^3 OR
  • Absolute neutrophil count at least 1,800/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT no greater than 50 U/L
  • PT and PTT less than 1.25 times normal (not on warfarin)

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance greater than 50 mL/min

Cardiovascular:

  • No congestive heart failure or myocardial infarction within the past 6 months
  • No uncompensated coronary artery disease
  • No severe peripheral vascular disease
  • No peripheral vascular disease with diabetes mellitus
  • No deep venous or arterial thrombosis within the past 3 months
  • Fibrin split products less than 2 times normal
  • Fibrinogen greater than 200 mg/dL

Pulmonary:

  • No pulmonary embolism within the past 3 months

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No contraindications to surgery
  • No active uncontrolled bacterial, viral, or fungal infection
  • No other prior or concurrent malignancy within the past 5 years except surgically treated carcinoma in situ of the cervix or squamous cell or basal cell skin cancer
  • No other serious medical or psychiatric illness that would preclude informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy for soft tissue sarcoma

Chemotherapy:

  • No prior chemotherapy for soft tissue sarcoma

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy for soft tissue sarcoma

Surgery:

  • At least 2 weeks since prior minor surgery (e.g., port placement)
  • At least 4 weeks since prior major surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00023725

  Show 226 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Burton L. Eisenberg, MD Fox Chase Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00023725     History of Changes
Other Study ID Numbers: CDR0000068854, RTOG-S-0120
Study First Received: September 13, 2001
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I adult soft tissue sarcoma

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013