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ZD1839 (IRESSA) In Tamoxifen-Resistant Metastatic Breast Cancer


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

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Trial Information

ZD1839 (IRESSA) In Tamoxifen-Resistant Metastatic Breast Cancer


OBJECTIVES:

Primary

- Compare the rate of clinical benefit in patients with tamoxifen-resistant breast cancer
treated with gefitinib with or without tamoxifen.

Secondary

- Determine the toxic effects of these regimens in these patients.

- Determine whether changes in fludeoxyglucose F 18 uptake by positron emission
tomography scan and changes in plasma DNA levels are indicators of an early response to
gefitinib in these patients.

- Determine the pharmacokinetics of these regimens in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to population (intent-to-treat population comprising all patients who
receive 1 dose of treatment vs a subset of the intent-to-treat population, excluding
patients with nonmeasurable/evaluable only disease). Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive oral tamoxifen once daily. Beginning 14 days after the start of
tamoxifen, patients receive oral gefitinib once daily.

- Arm II: Patients receive oral placebo once daily. Beginning 14 days after the start of
placebo, patients receive oral gefitinib as in arm I.

In both arms, treatment continues for 26 weeks in the absence of disease progression or
unacceptable toxicity.

Patients are followed for 6 months.

PROJECTED ACCRUAL: A total of 46 patients (23 per treatment arm) will be accrued for this
study within 23 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed breast cancer

- Metastatic disease

- Initial clinical benefit from tamoxifen for metastatic disease, defined by 1 of the
following:

- Stable disease for 24 weeks or longer

- Objective tumor response

- Documentation of clinical progression on tamoxifen within the past 6 weeks

- Hormone receptor status:

- Estrogen or progesterone receptor positive on most recently analyzed biopsy

PATIENT CHARACTERISTICS:

Age

- 18 and over

Sex

- Not specified

Menopausal status

- Not specified

Performance status

- ECOG 0-2

Life expectancy

- At least 6 months

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- AST ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

Renal

- Creatinine ≤ 1.5 times ULN OR

- Creatinine clearance ≥ 50 mL/min

Pulmonary

- No clinically active interstitial lung disease

- Patients with asymptomatic chronic stable radiographic changes are eligible

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No known hypersensitivity to gefitinib

- No other malignancy within the past 5 years except basal cell carcinoma or carcinoma
in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent trastuzumab (Herceptin®)

Chemotherapy

- No concurrent cytotoxic chemotherapy

Endocrine therapy

- See Disease Characteristics

- At least 2 weeks since other prior tamoxifen

- No concurrent hormone replacement therapy

- No other concurrent antiestrogens, including raloxifene

- No concurrent aromatase inhibitors

- No concurrent megestrol

- Concurrent systemic steroids for reasons other than skin toxicity allowed provided
the steroids were initiated before study entry AND dose remains stable

Radiotherapy

- Concurrent palliative radiotherapy as short-term treatment for symptomatic bone
metastases allowed provided other evaluable sites of disease are present AND
treatment lasts no more than 14 days

Surgery

- Recovered from prior oncologic or other major surgery

- No concurrent surgery during and for 7 days after study treatment

- No concurrent ophthalmic surgery

Other

- Recovered from all prior therapy (except alopecia)

- More than 30 days since prior investigational drugs

- No other concurrent investigational agents

- No concurrent administration of any of the following:

- Phenytoin

- Carbamazepine

- Barbiturates

- Rifampin

- Phenobarbital

- Hypericum perforatum (St. John's wort)

- Systemic retinoids

- CYP3A4 inhibitors (e.g., itraconazole)

- Drugs that cause significant sustained elevation in gastric pH ≥ 5

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Clinical benefit rate (complete response, partial response, and stable disease) for 26 weeks

Outcome Time Frame:

26 weeks

Safety Issue:

No

Principal Investigator

Gary N. Schwartz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Norris Cotton Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000355145

NCT ID:

NCT00080743

Start Date:

January 2004

Completion Date:

November 2005

Related Keywords:

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

Name

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002