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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Paula Silverman, PhD, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00054275
First received: February 5, 2003
Last updated: December 23, 2012
Last verified: December 2012
  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 2

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:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000 [ Time Frame: after 6 course (6 months) of combination therapy ] [ Designated as safety issue: No ]
    Response and progression will be evaluated in this study using the criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive Disease: At least a 20% increase in the sum of the LD of target lesions. Stable Disease: Neither sufficient shrinkage nor sufficient increase.


Secondary Outcome Measures:
  • Progression Free Survival(PFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Progression free survival was defined as time from the start of treatment to the date of cancer progression, or death, and censored at the date of last follow-up for those without disease progression and still alive. Stable disease is measured from the start of the treatment until progression, taking as reference the smallest measurements recorded since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

  • Overall Survival as of 2008 [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
    Overall survival (OS) was defined as time from the start of treatment to death, and censored at the time of last assessment for survivors.


Enrollment: 39
Study Start Date: December 2002
Study Completion Date: November 2012
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib Plus Docetaxel Drug: 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.
Other Names:
  • Taxotere
  • RP 56976
  • NSC #628503
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.
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 (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Paula Silverman, PhD
Investigators
Principal Investigator: Paula Silverman, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Paula Silverman, PhD, Principal Investigator, 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
Results First Received: February 21, 2012
Last Updated: December 23, 2012
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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014