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LY231514 in Treating Patients With Locally Advanced or Metastatic Solid Tumors and Varying Degrees of Kidney Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003706
Recruitment Status : Completed
First Posted : March 15, 2004
Last Update Posted : June 28, 2012
Lily Research Laboratories
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemotherapy drugs may have different effects in patients with different degrees of kidney function.

PURPOSE: Phase I trial to study the effectiveness of LY231514 in treating patients who have locally advanced or metastatic solid tumors and varying degrees of kidney function.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: pemetrexed disodium Phase 1

Detailed Description:

OBJECTIVES: I. Determine the toxic effects and maximum tolerated dose (MTD) of LY231514 in patients with metastatic or locally advanced solid tumors and varying degrees of renal function. II. Determine the recommended dose for LY231514 in this patient population. III. Examine the effects of renal dysfunction on the pharmacokinetics of LY231514 in this patient population. IV. Examine the relationship between impaired renal function, drug exposure, and drug effects in these patients. V. Gather data for development of a LY231514 dosing nomogram based on renal function. VI. Collect preliminary data regarding antitumor effects of LY231514 in this patient population.

OUTLINE: This is an open label, dose escalation study. Patients are stratified according to renal function. Group 1 consists of patients with normal renal function, and groups 2, 3, and 4 consist of patients with mild, moderate, and severe renal impairment. All patients receive LY231514 IV over 10 minutes every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated with escalating doses of LY231514 within each treatment group. If dose limiting toxicity (DLT) is observed in 1 of 3 patients at a given dose level, then 3 additional patients are studied. The maximum tolerated dose is defined as the dose level at which less than 2 of 6 patients experience DLT. Patients are followed until death.

PROJECTED ACCRUAL: Up to 50 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Pharmacokinetic Trial of LY231514 Administered Intravenously Every 3 Weeks in Advanced Cancer Patients With Varying Degrees of Renal Function
Study Start Date : April 1998
Actual Primary Completion Date : June 2002
Actual Study Completion Date : June 2002

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or locally advanced solid tumors that have failed standard therapy or for which no standard therapy exists Measurable or evaluable disease No active, symptomatic brain metastases No leukemia, lymphoma, or multiple myeloma No significant pleural or peritoneal effusions

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 3 times ULN (no greater than 5 times ULN if due to liver disease) Albumin at least 2.0 g/dL Renal: Not specified Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No active infection or serious concurrent systemic disorders No second primary malignancy in the past 5 years except carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin No body surface area greater than 3 m2

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No concurrent routine use of filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy (except contraceptives and corticosteroids) Radiotherapy: At least 4 weeks since prior radiotherapy (including wide field pelvic radiation) No concurrent radiotherapy Surgery: Not specified Other: At least 4 weeks since prior investigational agents Concurrent warfarin and heparin allowed No aspirin and other nonsteroidal antiinflammatory 2 days before, the day of, and 2 days after LY231514 administration (5 days for long-acting agents) No concurrent nonsteroidal antiinflammatory drugs or salicylates with a long half-life e.g., naproxen, piroxicam, diflunisal, or nabumetone) No other concurrent experimental medications No concurrent dialysis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003706

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United States, Texas
San Antonio Cancer Institute
San Antonio, Texas, United States, 78229-3264
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Lily Research Laboratories
National Cancer Institute (NCI)
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Study Chair: Eric K. Rowinsky, MD San Antonio Cancer Institute
Publications of Results:
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Responsible Party: The University of Texas Health Science Center at San Antonio Identifier: NCT00003706    
Other Study ID Numbers: CDR0000066814
P30CA054174 ( U.S. NIH Grant/Contract )
UTHSC-9785011141 ( Other Identifier: UTHSCSA IRB )
LILLY-H3E-MC-JMAW(a) ( Other Identifier: Eli Lilly )
SACI-IDD-97-29 ( Other Identifier: San Antonio Cancer Institute )
NCI-V98-1500 ( Other Identifier: NCI )
First Posted: March 15, 2004    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012
Keywords provided by The University of Texas Health Science Center at San Antonio:
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors