Here's another SERM (SBH's Idoxifene) in Phase III trials for the treatment of breast cancer (similar to the PFE Droloxifene trial that was switched to breast cancer prevention trial):
Phase III Study of Idoxifene vs Tamoxifen in Postmenopausal Women with Metastatic Breast
Cancer
Summary Last Modified: 04/98
Protocol IDs: SB-223030/010, NCI-V98-1383
Protocol Type: treatment
Sponsorship: pharmaceutical
Status: Active, New
Age Range: 18 and over (postmenopausal)
PROJECTED ACCRUAL:
A total of 440 patients will be accrued for this study within 3 years.
OBJECTIVES:
I. Compare the response rates and time to progression in patients with
metastatic breast cancer treated with idoxifene or tamoxifen as first line
hormonal therapy.
II. Compare the time to response, response duration, and survival rates of
these patients after these treatments.
III. Compare the toxic effects of these two treatments in these patients.
IV. Determine and compare the effects of these two treatments on the
patients' quality of life.
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Histologically or cytologically proven primary breast cancer
Clinical or radiological evidence of stage IV breast cancer
Measurable or evaluable disease
Evaluable lytic bone lesions allowed
Progressive disease occurred greater than 12 months after prior adjuvant
hormonal therapy
No inflammatory breast cancer
Hormone receptor status:
Estrogen receptor positive OR
Progesterone receptor positive
--Prior/Concurrent Therapy--
Biologic therapy:
At least 4 weeks since prior immunotherapy
No concurrent immunotherapy
Chemotherapy:
At least 4 weeks since prior chemotherapy
No greater than 1 prior chemotherapy regimen for breast cancer (except
adjuvant chemotherapy)
No concurrent chemotherapy
Endocrine therapy:
At least 12 months since prior adjuvant hormonal therapy (e.g., tamoxifen)
No other prior hormonal therapy
No concurrent chronic corticosteroids
No other concurrent hormonal therapy
Radiotherapy:
No concurrent radiotherapy
Palliative radiotherapy of bone lesions allowed, if not only site of study
disease
Surgery:
At least 2 weeks since major surgery and/or recovered
Other:
At least 30 days or 5 half-lives (whichever is longer) since prior
investigational therapy
No concurrent coumarin type anticoagulants
No concurrent bisphosphonates if bone is the only site of study disease
--Patient Characteristics--
Age:
18 and over
Sex:
Female
Menopausal status:
Postmenopausal
FSH at least 35 IU/L AND
LH at least 40 IU/L
Performance status:
ECOG 0-2
Life expectancy:
At least 4 months
Hematopoietic:
WBC at least 3500/mm3
Neutrophil count at least 1500/mm3
Platelet count at least 100,000/mm3
Hemoglobin at least 9.0 g/dL (transfusion allowed)
Hepatic:
Bilirubin no greater than 2.0 mg/dL
SGOT and SGPT no greater than 2 times upper limit of normal (ULN) (no greater
than 5 times ULN if liver metastases present)
Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN
if liver metastases present)
Renal:
Creatinine no greater than 1.5 ULN OR
Creatinine clearance at least 60 mL/min
Other:
No known hypersensitivity to tamoxifen or tamoxifen analogues
No concurrent medical or psychiatric conditions
No prior malignancies within 5 years except:
Curatively treated basal and squamous cell skin cancer
Curatively treated carcinoma in situ of the cervix
PROTOCOL OUTLINE:
This is a randomized, double blind, multicenter study.
Patients are randomized to receive either idoxifene or tamoxifen. Idoxifene
is administered orally, 2 tablets daily for 21 days, then 1 tablet daily for
the duration of therapy. Tamoxifen is also administered orally, 1 tablet of
tamoxifen plus 1 tablet of placebo given for 21 days, then 1 tablet of
tamoxifen for the duration of therapy. Patients may continue on therapy until
disease progression or unacceptable toxicity occurs.
Patients complete a quality of life questionnaire every 3 months for the
duration of the study.
Patients are followed every 3 months for survival.
WARNING:
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.
PARTICIPATING ORGANIZATIONS/INVESTIGATORS
Robert Eric Corringham, Chair,
SmithKline Beecham |
