Docetaxel and Temozolomide in Treating Patients With Metastatic Cancer

NCT00401180 | Completed Phase 1

• 2 other identifiers: CASE-CCF-4737P30CA043703
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose

  4 cycles

• Dose-limiting toxicity

  4 cycles

Interventions

docetaxel DRUG

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

temozolomide DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Related Publications (1)

• 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.

  PMID: 18626572 RESULT

MeSH Terms

Interventions

Docetaxel; Temozolomide

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Dacarbazine; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ronald M. Bukowski, MD

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 16, 2006
• First Posted: November 17, 2006
• Study Start: June 1, 2002
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: July 8, 2011

Record last verified: 2007-09

Locations

US (1)