SU6668 in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase I trial to study the effectiveness of SU6668 in treating patients who have advanced solid tumors. SU6668 may stop the growth of solid tumors by stopping blood flow to the tumor

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Orantinib

Criteria

Inclusion Criteria:

• Histologically confirmed advanced solid tumor for which no standard therapy exists

• At least 1 measurable tumor lesion (at least 2 cm) not previously irradiated

• No history of brain metastases

• Negative brain CT/MRI required for patients with signs and symptoms suspicious for brain metastases

• Performance status - ECOG 0-1

• WBC greater than 3,000/mm^3

• Absolute neutrophil count greater than 1,500/mm^3

• Platelet count greater than 100,000/mm^3

• Hemoglobin greater than 10 g/dL

• No history of bleeding diathesis

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• ALT less than 2.5 times ULN

• Creatinine less than 1.5 mg/dL

• Creatinine clearance greater than 60 mL/min

• No concurrent uncontrolled medical or psychiatric disorders

• No severe iodine allergy

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• At least 30 days since prior over-the-counter, anticancer biologic agents (e.g., shark cartilage)

• No concurrent over-the-counter, anticancer biologic agents (e.g., shark cartilage)

• At least 3 weeks since prior cytotoxic or cytostatic agents (6 weeks for nitrosoureas or mitomycin)

• Patients with ECOG performance status 0:

• Any number of prior chemotherapy regimens allowed

• Patients with ECOG performance status 1:

• No more than 3 prior chemotherapy regimens for metastatic or recurrent disease

• The same drug given on a different schedule does not count as a different regimen

• Prior adjuvant chemotherapy for non-metastatic disease or as part of a concurrent chemoradiotherapy protocol is allowed but does not count as part of the 3-regimen limit

• See Disease Characteristics

• See Chemotherapy

• At least 3 weeks since prior radiotherapy to nonindicator lesions

• No concurrent radiotherapy

• At least 24 hours since prior minor surgery (e.g., central venous catheter placement)

• At least 4 weeks since prior major surgery (e.g., laparotomy, thoracotomy, or craniotomy)

• At least 30 days since prior anticancer herbal remedies

• At least 30 days since prior investigational agents

• No concurrent anticancer herbal remedies

• No other concurrent investigational or anticancer medication