LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors - Full Text View

Sponsor:	University of California, Los Angeles
Collaborator:	National Cancer Institute (NCI)
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00052273

Purpose

RATIONALE: LY317615 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth and by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining LY317615 with capecitabine may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining LY317615 with capecitabine in treating patients who have advanced solid tumors.

Condition	Intervention	Phase
Adult Solid Tumor	Drug: capecitabine Drug: enzastaurin hydrochloride	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	A Phase I Dose Escalation Study With Oral LY317615 in Combination With Capecitabine in Advanced Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Capecitabine Enzastaurin Enzastaurin Hydrochloride

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Enrollment:	16
Study Start Date:	December 2002
Study Completion Date:	October 2005
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

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

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.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists
Measurable or evaluable disease
18 and over
ECOG 0-2
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- 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
Able to swallow capsules
Negative pregnancy test
Fertile patients must use effective contraception during and for 3-6 months after study
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
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin).
Radiotherapy
- At least 4 weeks since prior radiotherapy
- At least 2 weeks since prior palliative radiotherapy
- Recovered from prior therapy
Other
- 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

Exclusion Criteria:

known untreated or symptomatic CNS metastases
concurrent hematologic malignancies
gastrointestinal disorder that would interfere with oral drug absorption
serious concurrent systemic disorder
compliance issues that would preclude study
geographical conditions that would preclude study
active infection
prior hypersensitivity to any component of study drugs
pregnant or nursing
concurrent immunotherapy
concurrent routine filgrastim (G-CSF)
other concurrent chemotherapy
other concurrent hormonal therapy
concurrent radiotherapy (including palliative therapy)
other concurrent experimental medications
other concurrent anticancer therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052273

Locations

United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781

Sponsors and Collaborators

University of California, Los Angeles

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Carolyn Britten, MD

Jonsson Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Carolyn Britten, University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00052273 History of Changes
Other Study ID Numbers:	CDR0000258138, P30CA016042, UCLA-0206061, LILLY-H6Q-MC-JCAH, NCI-G02-2132
Study First Received:	January 24, 2003
Last Updated:	June 16, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:

unspecified adult solid tumor
protocol specific

Additional relevant MeSH terms:

Neoplasms
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012