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

NCT00054275 | Completed Phase 2 Results DMC

• 4 other identifiers: CWRU1102P30CA04370307-02-14MCASE-CWRU-1102
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage IV breast cancer; male breast cancer

Outcome Measures

Primary Outcomes (1)

• Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000

  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.

  after 6 course (6 months) of combination therapy

Secondary Outcomes (2)

• Progression Free Survival(PFS)

  3 years

• Overall Survival as of 2008

  5 yrs

Study Arms (1)

Erlotinib Plus Docetaxel

EXPERIMENTAL

Drug: docetaxel; Drug: erlotinib hydrochloride

Interventions

docetaxel 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.

Also known as: Taxotere, RP 56976, NSC #628503

Erlotinib Plus Docetaxel

erlotinib hydrochloride 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.

Also known as: CP-358, 774, USAN: erlotinib hydrochloride, Tarceva

Erlotinib Plus Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Paula Silverman, MD: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Docetaxel; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Paula Silverman, MD
• Organization: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

paula.silverman@uhhospitals.org

216-844-3951

Study Officials

• Paula Silverman, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2003
• First Posted: February 6, 2003
• Study Start: December 1, 2002
• Primary Completion: April 1, 2010
• Study Completion: November 1, 2012
• Last Updated: February 17, 2016
• Results First Posted: March 13, 2012

Record last verified: 2016-02

Locations

US (1)