Docetaxel and Temozolomide in Treating Patients With Metastatic Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00401180
• Date of registration: 16/11/2006
• Primary sponsor: The Cleveland Clinic
• Public title: Docetaxel and Temozolomide in Treating Patients With Metastatic Cancer
• Scientific title: Phase I Trial of Weekly Docetaxel and Daily Temozolomide in Patients With Metastatic Disease
• Date of first enrolment: June 2002
• Target sample size: 25
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00401180
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Ronald M. Bukowski, MD
• Affiliation: The Cleveland Clinic

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Unspecified Adult Solid Tumor, Protocol Specific

Intervention(s)

Drug: docetaxel

Drug: temozolomide

Primary Outcome(s)

Dose-limiting toxicity [Time Frame: 4 cycles]

Maximum tolerated dose [Time Frame: 4 cycles]

Secondary ID(s)

CASE-CCF-4737

P30CA043703

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)