Docetaxel and Temozolomide in Treating Patients With Metastatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00401180
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : July 8, 2011
National Cancer Institute (NCI)
Information provided by:
The Cleveland Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: docetaxel Drug: temozolomide Phase 1

Detailed Description:



  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Weekly Docetaxel and Daily Temozolomide in Patients With Metastatic Disease
Study Start Date : June 2002
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: docetaxel
    administered weekly in 5 escalating doses of 25 to 35 mg/ m(2) as a one-hour bolus intravenous infusion for 3 consecutive weeks.
    Drug: temozolomide
    administered orally daily for 3 weeks (escalating doses of 75 to 100 mg/m(2)). Cycles were repeated at 4 week intervals.

Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: 4 cycles ]
  2. Dose-limiting toxicity [ Time Frame: 4 cycles ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00401180

United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
The Cleveland Clinic
National Cancer Institute (NCI)
Study Chair: Ronald M. Bukowski, MD The Cleveland Clinic

Publications of Results:
Responsible Party: Robert Bukowski, Cleveland Clinic Taussig Cancer Institute Identifier: NCT00401180     History of Changes
Other Study ID Numbers: CASE-CCF-4737
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: November 17, 2006    Key Record Dates
Last Update Posted: July 8, 2011
Last Verified: September 2007

Keywords provided by The Cleveland Clinic:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents