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Phase I Trial of Weekly Docetaxel and Daily Temozolomide in Patients With Metastatic Disease

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Trial of Weekly Docetaxel and Daily Temozolomide in Patients With Metastatic Disease



- Determine the toxicity profile, dose-limiting toxicity, and maximum tolerated dose of
docetaxel and temozolomide (TMZ) in patients with metastatic cancer.


- Determine the activity of docetaxel and TMZ in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive docetaxel IV over 1 hour on days 1, 8, and 15 and oral temozolomide once
daily on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of
unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of docetaxel and temozolomide 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. A total of 6
patients receive treatment at the MTD.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Inclusion Criteria


- 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

- No active CNS metastasis


- 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


- See Disease Characteristics

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

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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

4 cycles

Safety Issue:


Principal Investigator

Ronald M. Bukowski, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Federal Government

Study ID:




Start Date:

June 2002

Completion Date:

July 2008

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific



Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065