Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer

NCT ID: NCT00054275

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2012-11-30

Brief Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with docetaxel may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining erlotinib with docetaxel in treating patients who have stage IV or recurrent breast cancer.

Detailed Description

OBJECTIVES:

• Determine the antitumor effects of erlotinib and docetaxel, in terms of objective response, stabilization of disease, and progression-free survival, in patients with stage IV or recurrent breast cancer.
• Determine time to tumor progression in patients treated with this regimen.
• Compare time to tumor progression in patients who achieve disease stabilization or response after treatment with this regimen and continue to receive erlotinib versus patients who do not receive additional erlotinib.

OUTLINE: Patients receive docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily beginning on day 1. Treatment repeats every 4 weeks for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients achieving maximal tumor response or stabilization of disease after 6 courses may continue to receive erlotinib alone until disease progression.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12-14 months.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Erlotinib Plus Docetaxel

Group Type: EXPERIMENTAL

docetaxel

Intervention Type: DRUG

Docetaxel IV infusion weekly for 3 weeks with a one-week break. One cycle is 4 weeks (28 days). Patients' actual weight will be used to calculate dose.

erlotinib hydrochloride

Intervention Type: DRUG

OSI-774 will be taken 1 hour before or 2 hours after meals. Cycle 1 will be administered at dose level -1.If no grade 3 or 4 toxicity occurs during cycle 1, then the patient may proceed to be treated at dose level 0 for the remaining chemotherapy cycles.

Interventions

docetaxel

Docetaxel IV infusion weekly for 3 weeks with a one-week break. One cycle is 4 weeks (28 days). Patients' actual weight will be used to calculate dose.

Intervention Type: DRUG

erlotinib hydrochloride

OSI-774 will be taken 1 hour before or 2 hours after meals. Cycle 1 will be administered at dose level -1.If no grade 3 or 4 toxicity occurs during cycle 1, then the patient may proceed to be treated at dose level 0 for the remaining chemotherapy cycles.

Intervention Type: DRUG

Other Intervention Names

Taxotere; RP 56976; NSC #628503; CP-358; 774; USAN: erlotinib hydrochloride; Tarceva

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage IV or recurrent adenocarcinoma of the breast
• Measurable disease
• Disease recurrence must not be within 1 year of receiving prior adjuvant docetaxel
• Stable brain metastases allowed
• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Male or female

Menopausal status

• Not specified

Performance status

• ECOG (Eastern Cooperative Oncology Group) 0-2 OR
• Karnofsky 60-100%

Life expectancy

• More than 6 months

Hematopoietic

• WBC(White Blood Count) at least 3,000/mm^3
• Platelet count at least 100,000/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Hemoglobin at least 8 g/dL

Hepatic

• Bilirubin normal
• AST(aspartate aminotransferase)/ALT(alanine aminotransferase) no greater than 2.5 times upper limit of normal

Renal

• Creatinine normal OR
• Creatinine clearance at least 60 mL/min
• No clinically significant proteinuria
• No significant impairment of renal function

Cardiovascular

• No New York Heart Association class III or IV heart disease
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• No inadequately controlled hypertension

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception
• No prior severe hypersensitivity reaction to docetaxel or drugs formulated with polysorbate 80
• No other malignancy within the past 10 years except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, or bilateral breast cancer
• No ongoing or active infection
• No peripheral neuropathy greater than grade 1
• No other concurrent uncontrolled medical condition that would preclude study participation
• No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior trastuzumab (Herceptin) allowed

Chemotherapy

• See Disease Characteristics
• No prior chemotherapy for recurrent or metastatic disease
• Prior adjuvant chemotherapy allowed

Endocrine therapy

• Prior hormonal therapy allowed

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No other concurrent investigational agents

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Paula Silverman, MD

OTHER

Sponsor Role: lead

Responsible Party

Paula Silverman, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Paula Silverman, MD

Role: PRINCIPAL_INVESTIGATOR

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Locations

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

07-02-14M

Identifier Type: OTHER

Identifier Source: secondary_id

CASE-CWRU-1102

Identifier Type: OTHER

Identifier Source: secondary_id

CWRU1102

Identifier Type: -

Identifier Source: org_study_id