|
|
Phase III Randomized Study of Docetaxel Versus Paclitaxel in Women With Metastatic or Locally Advanced, Inoperable Adenocarcinoma of the Breast
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Trial Contact Information Registry Information
Alternate Title
Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer
Basic Trial Information
|
Phase
|
|
|
|
Type
|
|
|
|
Status
|
|
|
|
Age
|
|
|
|
Sponsor
|
|
|
|
Protocol IDs
|
|
|
|
Phase III
|
|
|
|
Treatment
|
|
|
|
Completed
|
|
|
|
18 and over
|
|
|
|
Pharmaceutical / Industry
|
|
|
|
AVENTIS-56976-TAX-311 RP-56976-TAX-311, NCI-V95-0680, NCT00002662
|
|
|
Objectives - Compare the response rate in women with metastatic or locally advanced, inoperable adenocarcinoma of the breast treated with docetaxel vs paclitaxel.
- Compare the toxicity of these regimens in these patients.
- Compare the time to disease progression, duration of response, quality of life, and survival of patients treated with these regimens.
Entry Criteria Disease Characteristics:
- Histologically proven metastatic or locally advanced, inoperable adenocarcinoma of the breast
- Clinically evident metastases (e.g., clearly
malignant lesions on chest
x-ray or CT or abdominal CT do not require
histologic confirmation)
- Hot spots on bone scan not shown to be malignant on
plain x-rays are not
adequate evidence of malignant disease in the
absence of other lesions
- Must meet 1 of the following conditions:
- Disease progression after 1 prior chemotherapy
regimen for locally advanced
or metastatic disease (which may or may not have
followed a separate
adjuvant regimen using chemotherapy or hormonal
therapy)
- Locally advanced or metastatic disease during or after
1 adjuvant or
neoadjuvant chemotherapy regimen
- One of the above chemotherapy regimens must have
contained an anthracycline (e.g., doxorubicin, but not mitoxantrone)
- Single drug substitution (e.g., methotrexate for
doxorubicin) during prior
combination chemotherapy allowed
- Bidimensionally measurable
- No clinical or radiographic evidence of brain or leptomeningeal disease
- Hormone receptor status:
Prior/Concurrent Therapy:
Biologic therapy: - No prior bone marrow or stem cell transplantation
Chemotherapy: - See Disease Characteristics
- At least 3 weeks since prior chemotherapy (2 weeks for oral
cyclophosphamide or 6 weeks for nitrosoureas or mitomycin)
- No prior high-dose chemotherapy given with ablative
intent
- No prior taxoids
- No other concurrent antineoplastic therapy
Endocrine therapy: - See Disease Characteristics
- Prior hormonal therapy as adjuvant therapy or for metastatic
disease allowed
- At least 1 week since prior hormonal therapy
- No concurrent corticosteroids except:
- Prophylaxis or treatment for acute hypersensitivity
reactions
- Chronic therapy (more than 6 months) at low doses (20 mg/day
or less of methylprednisolone or equivalent)
Radiotherapy: - At least 4 weeks since prior radiotherapy to major bone marrow
areas
- No prior high-dose radiotherapy given with ablative
intent
- No concurrent radiotherapy except limited palliative
radiotherapy (e.g., for a solitary rib fracture) during objective response
Surgery: - See Disease Characteristics
- More than 2 weeks since prior surgery except simple biopsy or
placement of venous access device
Other: - At least 4 weeks since prior investigational drugs
- Concurrent medications known to alter cardiac conduction
(e.g., digoxin, beta blockers, or calcium channel blockers) allowed
- No concurrent ketoconazole
- No concurrent bisphosphonates unless initiated more than 3
months before randomization
- No concurrent experimental drug or therapy
Patient Characteristics:
Age: Sex: Menopausal status: Performance status: - Karnofsky 60-100%
OR - ECOG 0-2
Life expectancy: Hematopoietic: - Absolute neutrophil count at least 2,000/mm3
- Platelet count at least 100,000/mm3
Hepatic: - Bilirubin normal
- SGOT no greater than 2.5 times upper limit of normal
Renal: - Creatinine no greater than 2.0 mg/dL
- No uncontrolled hypercalcemia
Cardiovascular: - No myocardial infarction within the past 6 months
- No history of arrhythmia requiring treatment
- No heart block
- No clinical evidence of congestive heart failure
- No unstable angina (e.g., new onset, crescendo, or rest
angina)
- Stable exertional angina allowed
Other: - No current symptomatic grade 2 or greater peripheral
neuropathy
- No history of hypersensitivity to products containing
Cremophor EL (e.g., cyclosporine or teniposide) or Polysorbate 80 (e.g., IV
etoposide)
- No serious infection
- No significant psychiatric disease that would preclude
study
- No other malignancy within the past 5 years except
nonmelanomatous skin cancer or completely excised carcinoma in situ of the
cervix
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Expected Enrollment A total of 400 patients (200 per arm) will be accrued for this study. Outline This is a randomized, open-label, multicenter study. Patients are
randomized to 1 of 2 treatment arms. - Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses
repeat every 3 weeks in the absence of disease progression or unacceptable
toxicity.
- Arm II: Patients receive paclitaxel IV over 3 hours on day 1. Courses
repeat every 3 weeks in the absence of disease progression or unacceptable
toxicity.
Quality of life is assessed at baseline and after courses 4 and 6.
Patients are followed every 3 months.
Trial Contact Information
Trial Lead Organizations Aventis Pharmaceuticals, Incorporated | | | Peter Ravdin, MD, Protocol chair | | | |
Registry Information | | Official Title | | PHASE III COMPARISON OF TAXOTERE (DOCETAXEL) AND TAXOL (PACLITAXEL) IN PATIENTS WITH ADVANCED BREAST CANCER | | Trial Start Date | | 1994-08-15 | | Registered in ClinicalTrials.gov | | NCT00002662 | | Date Submitted to PDQ | | 1994-08-15 | | Information Last Verified | | 2004-04-13 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
|