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Prospective Evaluation of Body Surface Area (BSA) as a Determinant of Paclitaxel Pharmacokinetics/Pharmacodynamics in Women With Solid Tumors


Phase 2
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Prospective Evaluation of Body Surface Area (BSA) as a Determinant of Paclitaxel Pharmacokinetics/Pharmacodynamics in Women With Solid Tumors


OBJECTIVES: I. Evaluate the relationships between body surface area (BSA) and toxic effects,
BSA and pharmacokinetics, and pharmacokinetics and toxic effects in women with recurrent
solid tumors who receive a fixed total dose of paclitaxel. II. Determine the toxic effects
of paclitaxel in these patients. III. Assess the pharmacokinetics of paclitaxel in these
patients.

OUTLINE: Patients receive single fixed dose intravenous paclitaxel over 3 hours on day 1.
Blood samples must be drawn prior to the first paclitaxel infusion and then at 1, 6, and 24
hours after the start of the infusion during course 1 only. Treatment courses of intravenous
paclitaxel are repeated every 3 weeks at the discretion of the treating physician. Patients
are evaluated for response after the second course. Patients are followed at the discretion
of the physician.

PROJECTED ACCRUAL: A total of 50 patients will be accrued over 13 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven recurrent adult solid tumors Must have
measurable or evaluable disease No known bone marrow metastasis

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Women Performance Status: Zubrod 0-2 Life
Expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than
2.0 times upper limit of normal Renal: Creatinine no greater than 1.5 times upper limit of
normal Other: Concurrently active secondary malignancies are allowed

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
paclitaxel therapy No more than 1 prior chemotherapy regimen for metastatic disease At
least 4 weeks since chemotherapy Greater than 6 weeks since nitrosoureas, melphalan, or
mitomycin Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since
radiotherapy No prior whole pelvic radiation Surgery: At least 4 weeks since major surgery

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Principal Investigator

Antonius A. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Federal Government

Study ID:

CDR0000065893

NCT ID:

NCT00003130

Start Date:

November 1997

Completion Date:

January 2006

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Rhode Island HospitalProvidence, Rhode Island  02903
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Holden Comprehensive Cancer Center at The University of IowaIowa City, Iowa  52242-1009
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
North Shore University HospitalManhasset, New York  11030
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
University of Illinois at Chicago Health Sciences CenterChicago, Illinois  60612
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503