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Paclitaxel in Treating Older Patients With Solid Tumors

Alliance for Clinical Trials in Oncology logo

Alliance for Clinical Trials in Oncology

Status and phase

Completed
Phase 3

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Drug: paclitaxel

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00003092
CDR0000065800 (Registry Identifier)
CALGB-9762
U10CA031946 (U.S. NIH Grant/Contract)
CLB-9762

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase III trial to study the effectiveness of paclitaxel in treating older patients who have solid tumors.

Full description

OBJECTIVES:

  • Determine whether there is a relationship between pharmacokinetic measurements of paclitaxel and aging.
  • Determine whether there is a relationship between the toxic effects of paclitaxel and aging.

OUTLINE: Patients are stratified according to age (cohort 1: patients 55 to 64 vs cohort 2: patients 65 to 75 vs cohort 3: patients 75 and over).

Enrollment

120 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

  • Histologically proven nonhematologic malignancy

PATIENT CHARACTERISTICS:

Age:

  • 55 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • 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 (ULN)

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No uncontrolled or severe cardiovascular disease

Other:

  • No serious intercurrent medical illnesses that in the judgement of the investigator compromise patient care
  • No psychiatric conditions that would preclude study
  • No requirement for antibiotics for active acute infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No more than one prior chemotherapy regimen allowed
  • No prior paclitaxel allowed

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiation therapy

Surgery:

  • Not specified

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 1 patient group

Paclitaxel
Experimental group
Description:
Patients receive a single dose of IV paclitaxel over 3 hours. Additional cycles of paclitaxel will be given at the discretion of the physician. Patients are followed for second malignancies, disease progression, and survival.
Treatment:
Drug: paclitaxel

Trial contacts and locations

32

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Data sourced from clinicaltrials.gov

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