Sunitinib or Cediranib for Alveolar Soft Part Sarcoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

July 18, 2011

Primary Completion Date

November 6, 2023

Study Completion Date

March 15, 2026

Conditions
Sarcoma, Alveolar Soft Part
Interventions
DRUG

Cediranib

Cediranib, a small molecule inhibitor of vascular endothelial growth factor (VEGF) receptor tyrosine kinases, is showing preliminary evidence of activity in patients with alveolar soft part sarcoma (ASPS).

DRUG

Sunitinib

Sunitinib, a small molecule inhibitor of vascular endothelial growth factor (VEGF) receptor tyrosine kinases, is showing preliminary evidence of activity in patients with alveolar soft part sarcoma (ASPS).

OTHER

Prochlorperazine

10mg every 6 hours orally as needed for nausea,

OTHER

Promethazine

12.5-25mg intravenous every 6 hours as needed for nausea.

OTHER

Benzodiazepine

If promethazine is inadequate, add benzodiazepine until acute nausea is controlled.

OTHER

Filgrastim

Therapeutic use per investigator's discretion according to American Society of Clinical Oncology (ASCO) guidelines.

OTHER

Sargramostim

Therapeutic use per investigator's discretion according to American Society of Clinical Oncology (ASCO) guidelines.

OTHER

Lomotil

2.5mg plus atropine sulfate 0.025mg/tablet dosed according to package insert.

OTHER

Loperamide

4mg by mouth (PO) after first unformed stool with 2mg PO every 2 hours as long as unformed stools continue.

OTHER

Vitamin B6

50-150mg orally each day for hand-foot syndrome.

OTHER

Aquaphor

Topical emollient for hand-foot syndrome.

DRUG

Acetaminophen

Analgesic for hand foot syndrome as needed.

DRUG

Levothyroxine

Replacement therapy for participants with increases in thyroid-stimulating hormone.

DRUG

Warfarin

2mg daily for prophylaxis of thrombosis.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH