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| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00390000 |
Purpose
RATIONALE: Vatalanib and pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vatalanib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving vatalanib together with pemetrexed disodium may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vatalanib when given together with pemetrexed disodium in treating patients with advanced solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: pemetrexed disodium Drug: vatalanib |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Study of PTK/ZK in Combination With Pemetrexed Disodium (ALIMTA®) |
| Estimated Enrollment: | 44 |
| Study Start Date: | May 2007 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of vatalanib. Patients are assigned to 1 of 2 treatment groups.
Cohorts of 3-6 patients receive escalating doses of vatalanib 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 (DLT) during the first 3 weeks of treatment.
In both groups, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who experience unacceptable toxicity without progressive disease may be retreated at a lower dose.
Patients treated at the MTD (group II) undergo blood collection periodically for pharmacokinetic and pharmacogenetic analysis, including polyglutamation, gene expression, and polymorphism studies using mass spectrometry and high-performance liquid chromatography (HPLC). Genes of interest include reduced folate carrier (RFC-1), MRP, folate receptor, BCRP, FPGS, methylenetetrahydrofolate reductase (MTHFR), methionine synthase, methylthioadenosine phosphorylase, TS, DHFR, and GARFT.
PROJECTED ACCRUAL: A total of 44 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 |
DISEASE CHARACTERISTICS:
Histologically confirmed advanced solid tumor
Pleural, peritoneal, or pericardial effusions allowed
Clinically significant effusions must be drained prior to treatment (e.g., symptomatic pleural or peritoneal effusion)
No symptomatic, untreated, or uncontrolled CNS metastases
PATIENT CHARACTERISTICS:
Fertile patients must use effective barrier contraception
No concurrent severe and/or uncontrolled medical conditions, including any of the following:
No impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of vatalanib, including any of the following:
PRIOR CONCURRENT THERAPY:
More than 4 weeks since prior major surgery (e.g., laparotomy) or open biopsy (2 weeks for minor surgery)
More than 4 weeks since prior full-field radiotherapy (2 weeks for limited-field radiotherapy)
Concurrent radiotherapy for symptom palliation to nontarget sites (e.g., painful pre-existing bony metastasis) allowed
Concurrent ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) with short elimination half-lives (e.g., fenoprofen, indomethacin, ketoprofen, tolmetin, meclofenamate) are allowed provided 1 of the following criteria are met:
Concurrent NSAIDs with longer half-lives (e.g., nabumetone, piroxicam, oxaprozin, naproxen, diflunisal, and other NSAIDs not mentioned previously) are allowed provided the following criterion is met:
No concurrent products that stimulate thrombopoiesis
No concurrent use of the following drugs:
Contacts and Locations| United States, Minnesota | |
| Mayo Clinic Cancer Center | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| Principal Investigator: | Julian Molina, MD, PhD | Mayo Clinic |
More Information
| Study ID Numbers: | CDR0000503856, MAYO-MC0515, MAYO-06-002065, NOVARTIS-CPTK787AUS16 |
| Study First Received: | October 18, 2006 |
| Last Updated: | November 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00390000 History of Changes |
| Health Authority: | Unspecified |
|
unspecified adult solid tumor, protocol specific |
|
Antimetabolites Pemetrexed Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Folic Acid Antagonists Protein Kinase Inhibitors Pharmacologic Actions Vatalanib |