Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer - Full Text View

Sponsor:	Case Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00054275

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: docetaxel Drug: erlotinib hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study Of The Weekly Administration Of Docetaxel In Combination With The Epidermal Growth Factor Receptor Inhibitor OSI-774 In Recurrent And/Or Metastatic Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docetaxel Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:

Disease response (tumor measurements) measured after every 2 courses [ Time Frame: after 6 course (6 months) of combination therapy ] [ Designated as safety issue: No ]
assess the response rate on combination OSI-774 and Docetaxel

Secondary Outcome Measures:

Progression free survival function [ Time Frame: at progression ] [ Designated as safety issue: No ]

Enrollment:	39
Study Start Date:	December 2002
Estimated Study Completion Date:	April 2015
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Other Names:

Taxotere
RP 56976
NSC #628503

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.

Other Names:

CP-358
774
USAN: erlotinib hydrochloride
Tarceva

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 0-2 OR
Karnofsky 60-100%

Life expectancy

More than 6 months

Hematopoietic

WBC 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/ALT 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054275

Locations

United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Paula Silverman, MD

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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00054275 History of Changes
Other Study ID Numbers:	CWRU1102, P30CA043703, 07-02-14M, CASE-CWRU-1102
Study First Received:	February 5, 2003
Last Updated:	November 8, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Case Comprehensive Cancer Center:

recurrent breast cancer
stage IV breast cancer
male breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Erlotinib

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012