Docetaxel and Temozolomide in Treating Patients With Metastatic Cancer

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and temozolomide, 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 docetaxel and temozolomide in treating patients with metastatic cancer.

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

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dacarbazine; Docetaxel; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed diagnosis of a nonhematologic malignancy that is refractory to standard therapy OR for which no standard therapy is available

• Measurable (by CT scan) or evaluable disease

• If palliative radiotherapy has been administered, the measurable disease must be outside the radiation port

• Prior brain metastasis allowed provided it was definitely treated with external-beam radiotherapy, gamma knife, or surgical resection and is clinically stable

• Repeat MRI or CT scans must demonstrate stabilization of disease 4 weeks after the definitive therapy is completed AND there must be no requirement for dexamethasone

• No active CNS metastasis

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy ≥ 4 months

• Absolute granulocyte count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 8.0 g/dL (epoetin alfa and/or transfusions allowed)

• Creatinine ≤ 2 mg/dL

• Bilirubin normal

• PT normal, unless the patient is on warfarin for prior deep vein thrombosis or pulmonary embolus, requiring INR maintained at 2.0 - 3.0

• Sodium and potassium normal

• AST and ALT ≤ 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 2.5 times ULN

• No decompensated cardiac arrhythmia or other severe cardiovascular disease (i.e., New York Heart Association [NYHA] class III-IV heart disease)

• Patients with clinically stable NYHA class III or IV heart disease require cardiac clearance

• No peripheral neuropathy > grade 1

• No infection requiring IV antibiotics within the past 14 days

• No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

• No HIV positivity

• No hepatitis B surface antigen or hepatitis C antibody positivity

• No pulmonary embolus within the past 3 weeks

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use 2 methods of effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No more than 3 courses of prior immunotherapy and/or chemotherapy for metastatic disease

• Interferon alfa in the adjuvant setting is not considered a course of prior therapy

• Patients who relapse on adjuvant interferon alfa must be off therapy for ≥ 3 weeks

• No prior stem cell or organ transplantation

• More than 21 days since prior immunotherapy or chemotherapy

• At least 21 days since prior hormonal therapy (except luteinizing hormone-releasing hormone [LHRH] agonists) or radiotherapy and recovered

• More than 21 days since prior surgery requiring general anesthesia

• No concurrent radiotherapy

• Concurrent LHRH agonist therapy allowed

• Concurrent physiologic replacement steroids allowed

• No other concurrent chemotherapy or thalidomide

• No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) during study chemotherapy