Treating Patients With Advanced Solid Tumors, Breast Cancer or Recurrent Ovarian Cancer

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have metastatic, recurrent, or locally advanced, ovarian cancer, breast cancer, or metastatic or unresectable solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein College of Medicine; Albert Einstein College of Medicine of Yeshiva University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Epothilones

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed metastatic or unresectable solid malignancy for which no standard or curative therapies exist or are no longer effective

• Metastatic, recurrent, or locally advanced breast, ovarian, or other cancer

• Hemoglobin at least 9.0 g/dL

• WBC at least 3,000/mm3

• Absolute neutrophil count at least 1,500/mm3

• Platelet count at least 100,000/mm3

• Bilirubin normal

• AST/ALT no greater than 3 times upper limit of normal

• Gilbert's syndrome allowed

• Creatinine no greater than 2 mg/dL

Exclusion Criteria:

• symptomatic congestive heart failure

• unstable angina pectoris

• cardiac arrhythmia

• grade 2 or greater clinical neuropathy

• prior allergy or hypersensitivity reaction (grade 2 or greater) to prior paclitaxel or other therapy containing Cremophor EL

• allergy or intolerance to steroids, diphenhydramine, cimetidine, or ranitidine

• uncontrolled concurrent illness

• active infection

• pregnant or nursing

• other concurrent anticancer therapies or commercial agents

• other concurrent investigational agents

• other concurrent highly active antiretroviral therapy for HIV-positive patients