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Sponsors and Collaborators: |
Princess Margaret Hospital, Canada National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00410553 |
RATIONALE: Drugs used in chemotherapy, such as E7389 and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of E7389 and gemcitabine in treating patients with metastatic or unresectable solid tumors.
Condition | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Drug: eribulin mesylate Drug: gemcitabine hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Halichondrin B Analog E7389 in Combination With Gemcitabine in Patients With Refractory or Advanced Solid Tumors |
Estimated Enrollment: | 36 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive E7389 IV and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 OR on days 1 and 8*. Treatment repeats every 28 or 21 days* in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of E7389 and gemcitabine hydrochloride 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.
NOTE: *If the MTD is determined at the first dose level of the 28-day schedule, subsequent patients are treated on a 21-day schedule and receive treatment on days 1 and 8.
After completion of study treatment, patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
At least 4 weeks since prior radiation therapy
No more than 2 prior chemotherapy regimens for advanced or metastatic incurable solid tumors
No concurrent inhibitors or inducers of CYP3A4
Canada, Ontario | |
Ottawa Hospital Regional Cancer Centre - General Campus | Recruiting |
Ottawa, Ontario, Canada, K1H 8L6 | |
Contact: Rakesh Goel, MD, FRCPC 613-737-7700 ext. 70171 rgoel@ottawahospital.on.ca | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Amit M. Oza, MD 416-946-2818 |
Study Chair: | Rakesh Goel, MD, FRCPC | Ottawa Hospital Regional Cancer Centre - General Campus |
Study ID Numbers: | CDR0000520315, PMH-PHL-048 |
Study First Received: | December 11, 2006 |
Last Updated: | January 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00410553 History of Changes |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific |
Antimetabolites Radiation-Sensitizing Agents Immunologic Factors |
Gemcitabine Immunosuppressive Agents Antiviral Agents |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses Gemcitabine |