R115777 in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of R115777 in treating patients who have advanced solid tumors.

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

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Tipifarnib

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed malignant tumors deemed to be incurable or refractory to therapy

• Advanced, recurrent, or metastatic disease

• Previously treated with at least 1 chemotherapy regimen

• Brain metastases allowed if asymptomatic and controlled (e.g., after prior surgical resection or radiotherapy/radiosurgery) and not on steroids or anticonvulsants

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,500/mm3

• Absolute granulocyte count at least 1,500/mm3

• Platelet count at least 75,000/mm3

Hepatic:

• Bilirubin no greater than 2.5 times upper limit of normal (ULN)

• SGOT no greater than 2.5 times ULN

Renal:

• Creatinine clearance at least 60 mL/min OR

• Creatinine no greater than 1.6 mg/dL

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent biologic therapy

Chemotherapy:

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea)

Endocrine therapy:

• See Disease Characteristics

• No concurrent hormonal therapy

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy and recovered

• No prior radiotherapy to a field containing a measurable target lesion unless there is evidence of progression or a new lesion is present

• No concurrent radiotherapy to measurable lesions

Surgery:

• See Disease Characteristics

• At least 3 weeks since prior major surgery and recovered

Other:

• At least 2 weeks since prior proton pump inhibitors (e.g., omeprazole)

• Concurrent H2 blockers (e.g., cimetidine or related drugs) or antacids are allowed if there is an interval of at least 2 hours between H2 blocker/antacid intake and R115777 dosing