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A Multicenter Phase II Evaluation of Targretin (Bexarotene) Capsules in Patients With Advanced Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

A Multicenter Phase II Evaluation of Targretin (Bexarotene) Capsules in Patients With Advanced Breast Cancer


OBJECTIVES: I. Compare the efficacy of oral bexarotene (LGD1069) at two different dose
levels in patients with advanced breast cancer. II. Assess the safety and tolerability of
this treatment regimen in this patient population. III. Evaluate the efficacy of oral
bexarotene in terms of induction of differentiation and decreased aberrant cell
proliferation in these patients.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified
according to prior therapy for metastatic disease. Patients are randomized to one of two
dose levels. All patients receive oral bexarotene once daily. Treatment continues in the
absence of disease progression or unacceptable toxicity. Patients are followed every week
for the first month, at weeks 6 and 8, then monthly thereafter.

PROJECTED ACCRUAL: A total of 84-180 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed metastatic breast cancer No CNS
metastases No rapidly progressing visceral disease Previously irradiated lesions(s) may be
designated as measurable indicator tumor(s) only if more than 6 months since radiotherapy,
patient has no other measurable disease regrowth, and bidimensionally measurable regrowth
is documented within 2 months prior to study Stratum 1 (hormonal): Must be hormone
receptor positive (ER or PR) Prior hormonal therapy only allowed for metastatic disease
Must have progressed on last hormonal regimen Must have at least one bidimensionally
measurable tumor Stratum 2 (chemotherapy): Hormone receptor positive or negative Must have
progressed on or after prior chemotherapy (1-2 regimens) for metastatic disease (bone
marrow transplant counts as 2 regimens) Prior hormonal therapy allowed Must have at least
one bidimensionally measurable tumor Stratum 3 (tamoxifen): Must be hormone receptor
positive (ER or PR) and progressing on tamoxifen No symptomatic visceral metastasis if on
adjuvant tamoxifen at time of systemic recurrence Must have at least one bidimensionally
measurable tumor, or lytic bone lesion which measures at least one cm in diameter Hormone
receptor status: See above

PATIENT CHARACTERISTICS: Age: Over 18 Menopausal status: Not specified Performance status:
ECOG 0-2 OR Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: WBC at
least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least
100,000/mm3 Fasting triglycerides within normal range Hepatic: Bilirubin no greater than
1.5 times upper limit of normal (ULN) SGOT and/or SGPT no greater than 2.5 times ULN
Concurrent medication with drugs that significantly alter hepatic metabolism (e.g.,
phenobarbital, phenytoin, oral azole antifungals) allowed only if dosage stable Renal:
Creatinine less than 2 times ULN OR Creatinine clearance greater than 40 mL/min Concurrent
medication with drugs that significantly alter renal metabolism (e.g., probenecid) allowed
only if dosage stable Other: At least 5 years since any other prior invasive malignancy
except basal cell and squamous cell carcinoma of the skin No serious concurrent illness
that would prevent compliance No history of or clinically significant risk factors for
developing pancreatitis Fasting triglycerides within normal range Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior monoclonal antibody HER2 therapy for
metastatic disease allowed only if combined with chemotherapy or hormonal therapy and
treatment failed No concurrent immunotherapy Chemotherapy: See Disease Characteristics At
least 4 weeks since prior cytotoxic chemotherapy (at least 6 weeks since prior mitomycin
or nitrosourea) No prior retinoid therapy for breast cancer At least 3 months since any
other prior retinoid therapy except topical application for dermatological indications No
concurrent chemotherapy Endocrine therapy: See Disease Characteristics At least 2 weeks
since prior non-FDA approved hormonal therapy No other concurrent hormonal therapy except
chronic low dose hormone replacement therapy or low dose corticosteroids for noncancer
indication Radiotherapy: See Disease Characteristics Prior radiotherapy allowed Concurrent
radiotherapy allowed only to non-indicator tumor(s) that do not represent new disease or
disease progression Surgery: Prior surgery allowed Other: At least one month since prior
investigational therapy (except hormonal) No other concurrent investigational therapy
Concurrent medication with drugs that significantly alter hepatic metabolism (e.g.,
phenobarbital, phenytoin, oral azole antifungals) allowed only if dosage stable No more
than 15,000 IU of vitamin A consumed daily

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

George D. Demetri, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

LIGAND-L1069-34

NCT ID:

NCT00003752

Start Date:

October 1998

Completion Date:

March 2003

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Vincent T. Lombardi Cancer Research Center, Georgetown UniversityWashington, District of Columbia  20007
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
Sarah Cannon-Minnie Pearl Cancer CenterNashville, Tennessee  37203
Beckman Research Institute, City of HopeLos Angeles, California  91010
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Baptist Regional Cancer Institute - JacksonvilleJacksonville, Florida  32207
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Oregon Cancer Center at Oregon Health Sciences UniversityPortland, Oregon  97201-3098
Michigan State UniversityEast Lansing, Michigan  48824
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Mayo Clinic JacksonvilleJacksonville, Florida  32224
Hematology Oncology Consultants IncColumbus, Ohio  43235
Kaiser Permanente-Southern California Permanente Medical GroupSan Diego, California  92120
Louisiana State University School of MedicineNew Orleans, Louisiana  70112-2822
University of MinnesotaMinneapolis, Minnesota  55455