Completed

A Phase II Trial of SU5416 (NSC #696819) in Previously Treated Patients With Advanced, Metastatic and/or Locally Recurrent Soft Tissue Sarcomas

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

semaxanib

Drug
Who is being recruted

Digestive System Diseases+7

+ Digestive System Neoplasms

+ Gastrointestinal Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2000
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2000

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Determine the response rate, response duration, and overall survival in patients with advanced, metastatic, or recurrent soft tissue sarcoma or gastrointestinal stromal tumor when treated with SU5416. II. Determine the safety of SU5416 in these patients. OUTLINE: This is a multicenter study. Patients receive SU5416 IV twice weekly for 4 weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 3 months and then every 3 months for 1 year.

Official TitleA Phase II Trial of SU5416 (NSC #696819) in Previously Treated Patients With Advanced, Metastatic and/or Locally Recurrent Soft Tissue Sarcomas
NCT00005862
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms, Connective TissueSarcomaNeoplasms, Connective and Soft TissueGastrointestinal Stromal Tumors

Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed advanced, metastatic, recurrent, or unresectable soft tissue sarcoma or gastrointestinal stromal tumor * Measurable disease defined as lesions that can be measured in at least one dimension as at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan * Must have received prior chemotherapy with no response or progression after initial response * Evidence of disease progression in past 3 months * No CNS metastases or primary brain tumors PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: ECOG 0-1 * Life expectancy: At least 12 weeks * WBC greater than 2,000/mm3 * Platelet count greater than 100,000/mm3 * Fibrin split products no greater than 0.001 mg * Fibrinogen greater than 200 mg/dL * Bilirubin no greater than upper limit of normal (ULN) * AST/ALT less than 1.5 times ULN * PT/PTT less than 1.25 times ULN * Creatinine no greater than 1.5 mg/dL * At least 1 year since bypass surgery for atherosclerotic coronary artery disease * No uncompensated coronary artery disease * No history of myocardial infarction or unstable/severe angina in past 6 months * No severe peripheral vascular disease * No history of deep venous or arterial thrombosis in past 3 months * No history of pulmonary embolism in past 3 months * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No diabetes mellitus * No history of bleeding diathesis * No known active retroviral disease * No AIDS-associated Kaposi's sarcoma * No history of allergic reaction to Cremophor or paclitaxel * No uncontrolled illness or psychiatric disorder that would preclude study PRIOR CONCURRENT THERAPY: * No concurrent immunotherapy * At least 3 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas) * No concurrent chemotherapy * At least 3 weeks since prior radiotherapy * No concurrent radiotherapy * Greater than 2 weeks since prior minor surgery (greater than 4 weeks since major surgery) * No concurrent antiinflammatory drugs

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
atients receive SU5416 IV twice weekly for 4 weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Massachusetts General Hospital Cancer Center

Boston, United StatesOpen Massachusetts General Hospital Cancer Center in Google Maps
Suspended

Dana-Farber Cancer Institute

Boston, United States
Completed2 Study Centers
A Phase II Trial of SU5416 (NSC #696819) in Previously Treated Patients With Advanced, Metastatic and/or Locally Recurrent Soft Tissue Sarcomas | PatLynk