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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00401180

Docetaxel and Temozolomide in Treating Patients With Metastatic Cancer

A Phase 1 study testing docetaxel and temozolomide in people with Unspecified Adult Solid Tumor, Protocol Specific, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
docetaxel and temozolomide
How many people
25 participants
Where
1 siteUnited States
Study dates
Jun 2002to Jul 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

Other trials in United States

About this study

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

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.

Read the detailed description

OBJECTIVES:

Primary

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

Secondary

  • 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.

Being tested
docetaxel, temozolomide
Keywords
unspecified adult solid tumor, protocol specific

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • docetaxelDrug

    administered weekly in 5 escalating doses of 25 to 35 mg/ m(2) as a one-hour bolus intravenous infusion for 3 consecutive weeks.

  • temozolomideDrug

    administered orally daily for 3 weeks (escalating doses of 75 to 100 mg/m(2)). Cycles were repeated at 4 week intervals.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose

    Measured: 4 cycles

  2. Dose-limiting toxicity

    Measured: 4 cycles

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2006 (estimated)
  2. Study startJun 2002
  3. Primary completionJul 2008
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00401180
Sponsor's protocol ID
CASE-CCF-4737
Other IDs
P30CA043703, CASE-CCF-4737
Status last verified
Sep 2007
First submitted
16 Nov 2006
Last updated
8 Jul 2011
Results posted
No

Publications

  • Tamaskar I, Mekhail T, Dreicer R, Olencki T, Roman S, Elson P, Bukowski RM. Phase I trial of weekly docetaxel and daily temozolomide in patients with metastatic disease. Invest New Drugs. 2008 Dec;26(6):553-9. doi: 10.1007/s10637-008-9153-0. Epub 2008 Jul 15.

    PubMed 18626572

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing docetaxel and temozolomide in people with Unspecified Adult Solid Tumor, Protocol Specific, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (time frame: 4 cycles). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00401180, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2011.

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