A Phase 1 Study of Halichondrin B Analog (E7389) in Combination With Cisplatin in Advanced Solid Tumors

Inclusion Criteria:

- Histologically confirmed malignant solid tumor

- Advanced disease, meeting both of the following criteria: Metastatic or unresectable
disease and standard curative or palliative measures do not exist or are no longer
effective.

- No known active brain metastases

- Life expectancy > 3 months

- ECOG performance status 0-2

- Bilirubin 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.

- Negative pregnancy test

- Fertile patients must use effective contraception

- 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 more than 2 prior chemotherapy regimens for advanced solid tumors.

- No other concurrent investigational agents. Bisphosphonate therapy (e.g., pamidronate
or zolendronate) is not considered investigational therapy.

- No concurrent antiretroviral therapy for HIV-positive patients.

- No other concurrent anticancer agents or therapies.

- Tumor has spread to other parts of the body or cannot be removed by surgery.

- More than 4 weeks since chemotherapy, biological therapy, or radiation therapy.

- No more than two previous chemotherapy regimens for advanced solid tumor.

- WBC >= 3,000/mm^3

- Platelet count >= 100,000/mm^3

- Creatinine clearance >= 60 mL/min

- Absolute neutrophil count >= 1,500/mm³

- AST and ALT =< 2.5 times upper limit of normal

- No prior cumulative cisplatin dose > 300 mg/m^2

- No preexisting neuropathy <= grade 2

- Not pregnant or nursing