Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer
This study has been completed.
Sponsor:
Paula Silverman, PhD
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
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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:
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:
|
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
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 Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013