E7389 and Cisplatin in Treating Patients With Advanced Solid Tumors



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:December 2006

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A Phase I Study of Halichondrin B Analog (E7389) in Combination With Cisplatin in Advanced Solid Tumors


RATIONALE: Drugs used in chemotherapy, such as E7389 and cisplatin, 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
cisplatin in treating patients with advanced solid tumors.


OBJECTIVES:

- Determine the maximum tolerated dose of E7389 and cisplatin in patients with advanced
solid tumors.

- Determine the safety and toxicity of this regimen in these patients.

- Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive E7389 IV over 5 minutes on days 1 and 8 and cisplatin IV over 30-60 minutes
on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable
toxicity.

Cohorts of 3-6 patients receive escalating doses of E7389 and cisplatin until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which
at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients
are treated at the MTD.

Patients undergo blood collection periodically in course 1 for pharmacokinetic studies.

After completion of study treatment, patients are followed for up to 8 weeks.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

- Histologically confirmed malignant solid tumor

- Advanced disease, meeting both of the following criteria:

- Metastatic or unresectable disease

- Standard curative or palliative measures do not exist or are no longer effective

- No known active brain metastases

PATIENT CHARACTERISTICS:

- Life expectancy > 3 months

- ECOG performance status 0-2

- Bilirubin normal

- WBC ≥ 3,000/mm³

- Platelet count ≥ 100,000/mm³

- Creatinine clearance ≥ 60 mL/min

- Absolute neutrophil count ≥ 1,500/mm³

- AST and ALT ≤ 2.5 times upper limit of normal

- No uncontrolled intercurrent illness including, but not limited to, any of the
following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situation that would limit study compliance

- No preexisting neuropathy ≥ grade 2

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- Recovered from prior therapy

- No prior chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin
C)

- No prior targeted therapy within the past 4 weeks

- No prior immunotherapy within the past 4 weeks

- No prior radiotherapy within the past 4 weeks

- No prior cumulative cisplatin dose > 300 mg/m²

- No more than 2 prior chemotherapy regimens for advanced solid tumors

- No other concurrent investigational agents

- Bisphosphonate therapy (e.g., pamidronate or zoledronate) is not considered
investigational therapy

- No concurrent antiretroviral therapy for HIV-positive patients

- No other concurrent anticancer agents or therapies
We found this trial at
7
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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Duarte, CA
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2279 45th Street
Sacramento, California 95817
(916) 734-5800
University of California Davis Cancer Center At UC Davis Comprehensive Cancer Center, specialized teams of...
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Sacramento, CA
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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Los Angeles, CA
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2500 Alhambra Ave
Martinez, California 94553
(925) 370-5000
Contra Costa Regional Medical Center Contra Costa Health Services is the largest department of County...
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Martinez, CA
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Pasadena, California 91105
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Pasadena, CA
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5150 Centre Ave
Pittsburgh, Pennsylvania 15232
(412) 647-2811
University of Pittsburgh Cancer Institute Founded in 1985, the University of Pittsburgh Cancer Institute (UPCI)...
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Pittsburgh, PA
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