Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over NCI, Pharmaceutical / Industry UCLA-0206061 LILLY-H6Q-MC-JCAH, NCI-G02-2132, NCT00052273

Objectives

1. Determine the maximum tolerated dose and the recommended phase II dose of LY317615 and capecitabine in patients with advanced solid tumors.
2. Determine the safety profile of this regimen in these patients.
3. Determine the pharmacokinetics of this regimen in these patients.
4. Determine, preliminarily, the antitumor activity of this regimen in these patients.
5. Determine the effects of LY317615 on potential angiogenic surrogate markers in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists



• Measurable or evaluable disease



• No known untreated or symptomatic CNS metastases



• No concurrent hematologic malignancies

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent immunotherapy
• No concurrent routine filgrastim (G-CSF)

Chemotherapy

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• No other concurrent chemotherapy

Endocrine therapy

• At least 4 weeks since prior anticancer hormonal therapy
• At least 6 weeks since prior bicalutamide
• At least 4 weeks since prior flutamide or nilutamide
• Concurrent luteinizing hormone-releasing hormone analog therapy (e.g., leuprolide or goserelin) allowed for patients with prostate cancer if started before study entry
• No other concurrent hormonal therapy

Radiotherapy

• At least 4 weeks since prior radiotherapy
• At least 2 weeks since prior palliative radiotherapy
• No concurrent radiotherapy (including palliative therapy)

Surgery

• Not specified

Other

• Recovered from prior therapy
• At least 4 weeks since prior investigational anticancer therapy
• At least 4 weeks since other prior anticancer therapy
• At least 30 days since prior experimental drugs
• No other concurrent experimental medications
• No other concurrent anticancer therapy

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 9 g/dL (erythrocyte transfusions allowed)

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• ALT and AST no greater than 2.5 times ULN (5 times ULN if liver metastases present)

Renal

• Creatinine clearance at least 50 mL/min
• Potassium at least 3.4 mEq/L
• Calcium at least 8.4 mg/dL
• Magnesium at least 1.2 mEq/L

Cardiovascular

• QTc interval no greater than 450 msec in males
• QTc interval no greater than 470 msec in females
• No other electrocardiogram abnormalities

Other

• Able to swallow capsules
• No gastrointestinal disorder that would interfere with oral drug absorption
• No serious concurrent systemic disorder
• No compliance issues that would preclude study
• No geographical conditions that would preclude study
• No active infection
• No prior hypersensitivity to any component of study drugs
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3-6 months after study

Expected Enrollment

A total of 12-36 patients will be accrued for this study.

Outline

This is a dose-escalation study.

Patients receive oral LY317615 daily on days 1-14 (course 1 only). Beginning with course 2, patients receive oral LY317615 daily on days 1-21 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of LY317615 and capecitabine 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. Once the MTD is determined, additional patients are treated at the recommended phase II dose.

Patients are followed at 30 days after the last dose of study drug.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Carolyn Britten, MD, Principal investigator		Ph: 310-825-8195; 888-798-0719

Registry Information
Official Title		A Phase I Dose Escalation Study with Oral LY317615 in Combination with Capecitabine in Advanced Cancer Patients
Trial Start Date		2002-12-05
Registered in ClinicalTrials.gov		NCT00052273
Date Submitted to PDQ		2002-09-25
Information Last Verified		2004-10-29
NCI Grant/Contract Number		P30-CA16042

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