Chemotherapy, SU5416, Radiation Therapy, and Surgery in Treating Patients With Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT00023738|
Recruitment Status : Completed
First Posted : October 21, 2003
Last Update Posted : June 24, 2013
|First Submitted Date ICMJE||September 13, 2001|
|First Posted Date ICMJE||October 21, 2003|
|Last Update Posted Date||June 24, 2013|
|Start Date ICMJE||August 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00023738 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Chemotherapy, SU5416, Radiation Therapy, and Surgery in Treating Patients With Soft Tissue Sarcoma|
|Official Title ICMJE||A Phase I/II Study Of Neoadjuvant Chemotherapy, Angiogenesis Inhibitor SU5416 (NSC # 696819; A TK Inhibitor Anti-Angionesises Compound), And Radiation Therapy In The Management Of High Risk, High-Grade, Soft Tissue Sarcomas Of The Extremities And Body Wall|
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Drugs such as SU5416 may stop the growth of cancer by stopping blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy, SU5416, and radiation therapy before and after surgery may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy, SU5416, radiation therapy, and surgery in treating patients who have soft tissue sarcoma.
OUTLINE: This is a dose-escalation study of SU5416.
Patients receive neoadjuvant chemotherapy comprising doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 5 and continuing until blood counts recover. Patients undergo 2 courses of radiotherapy, given once daily for 11 doses per course over days 7-20 and 28-41. Patients also receive SU5416 IV over 1 hour twice weekly beginning on day 1 and continuing until 2 days before surgery. Patients undergo surgical resection on day 80. Patients then receive adjuvant chemotherapy comprising doxorubicin, ifosfamide, and dacarbazine IV continuously on days 101-103, 122-124, and 143-145. Patients also receive SU5416 IV over 1 hour twice weekly beginning on day 101 and continuing until the end of adjuvant chemotherapy. Patients with positive surgical margins receive additional radiotherapy beginning 2 weeks after resection for a total of 8 doses.
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.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 68-80 patients will be accrued for this study.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1
|Study Design ICMJE||Primary Purpose: Treatment|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||October 2003|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Canada, United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00023738|
|Other Study ID Numbers ICMJE||CDR0000068855
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Radiation Therapy Oncology Group|
|Collaborators ICMJE||National Cancer Institute (NCI)|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||December 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP