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Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004243
First Posted: April 18, 2003
Last Update Posted: January 13, 2010
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
City of Hope Medical Center
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of docetaxel and oxaliplatin in treating patients who have metastatic or recurrent solid tumor.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: docetaxel Drug: oxaliplatin Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of Oxaliplatin in Combination With Docetaxel (Taxotere) Metastatic/Recurrent Solid Tumors

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Study Start Date: March 2000
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel when followed by oxaliplatin in patients with metastatic or recurrent solid tumors. II. Describe the toxicities of this regimen in this patient population at each dose level studied. III. Evaluate the pharmacokinetics and pharmacodynamics of this regimen in these patients.

OUTLINE: This is a dose escalation study of docetaxel. Patients receive docetaxel IV over 1 hour followed by oxaliplatin IV over 2 hours on day 1 every 3 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Patients are followed for disease progression.

PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study within 2 years.

  Eligibility

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
Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or recurrent solid tumor that has failed standard therapy or for which no standard therapy exists No known brain metastases or carcinomatosis meningitis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 OR Karnofsky 60-100% Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.25 times ULN Calcium no greater than 12 mg/dL Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No evidence of neuropathy No history of allergy to platinum compounds No history of allergy to antiemetics appropriate for administration in conjunction with protocol directed chemotherapy No uncontrolled concurrent illness (e.g., ongoing or active infection) No medical, social, or psychological factors that would preclude consent and follow up

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: Prior chemotherapy, including fluorouracil and cisplatin, allowed At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Recovered from prior surgery Other: At least 30 days since other prior investigational drugs No other concurrent investigational or commercial agents or therapies No concurrent antiretroviral therapy (HAART)

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00004243


Locations
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033-0800
Beckman Research Institute, City of Hope
Los Angeles, California, United States, 91010
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Study Chair: Heinz-Josef Lenz, MD University of Southern California
  More Information

ClinicalTrials.gov Identifier: NCT00004243     History of Changes
Other Study ID Numbers: CDR0000067488
U01CA062505 ( U.S. NIH Grant/Contract )
CHNMC-PHASEI-24
CHNMC-IRB-99081
LAC-USC-OC-99-2
NCI-T99-0004
First Submitted: January 28, 2000
First Posted: April 18, 2003
Last Update Posted: January 13, 2010
Last Verified: January 2010

Keywords provided by City of Hope Medical Center:
unspecified adult solid tumor, protocol specific

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