MDACC Study Summary 2003-0992

Study Summary
No. 2003-0992:.......Breast......Banu Arun......Breast Medical Oncology

Study Summary Title



Study Summary Number:	2003-0992

Study Title:	Gemcitabine and R115777 Combination Therapy for Metastatic Breast Cancer

Physician

New Patient Referral



Name:	Banu Arun	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Breast Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2817 Contact us about clinical trials

General Information



Disease Group:	Breast	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Clinic Visits: Day 1: Physical examination and laboratory evaluation Day 8 : Laboratory evaluation and drug administration Cycles will be repeated every 3 weeks. Radiologic staging will be performed every 2 cycles.

Treatment Agents:	Gemcitabine R115777	Home Care:	The Tipifarnib (R115777)) is an oral formulation and will be taken at home by the patient.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Treatment will be given as an outpatient, no hospitalization is required.


Description/ Intervention:	The goal of this clinical research study is to find out if the combination of gemcitabine and Zarnestra (R115777) can shrink or slow the growth of breast cancer. The safety of this combination treatment will also be studied.

Study Objectives / Outcomes

1) To evaluate the objective response rate of the combination of Gemcitabine and the farnesyltransferase inhibitor Tipifarnib (R115777) in patients with metastatic breast cancer.

2) To evaluate the duration of response, time to disease progression in patients with metastatic breast cancer treated with the combination of Gemcitabine and Tipifarnib (R115777).

Study Status Information



Study Activation / Registration Date:	09/13/2005

IRB Review and Approval Date:	03/17/2004

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	45

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Age equal to or greater than 18.

2) Histologically confirmed breast cancer and clinical evidence of metastatic disease.

3) Patients may have received any number or type of hormonal therapies, either for Stage IV disease and/or as adjuvant therapy. Patients may have received trastuzumab therapy.

4) Patients may have received up to 2 prior chemotherapy regimens as therapy for metastatic breast cancer. Patients must have recovered from the myelosuppressive effects of prior chemotherapy and all toxicity must have recovered to grade < or equal to 1.

5) Concomitant bisphosphonates are allowed for patients with bone metastases.

6) Localized radiotherapy that does not influence the single evaluable lesion is allowed prior to the initiation of therapy. Patients must have recovered from the myelosuppressive effects of previous radiotherapy (at least 4 weeks).

7) Ability to understand and the willingness to sign a written informed consent.

8) Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.

9) ECOG performance status less than or equal to 2 (Karnofsky > 60%).

10) Patients must have normal organ and marrow function as defined: Leukocytes > or equal to 3,000/uL, absolute neutrophil count > or equal to 1,500/uL, platelets > or equal to 100,000/uL, total bilirubin within normal institutional limits, AST(SGOT) or ALT(SGPT) < or equal to 2.5 X institutional upper limit of normal, creatinine not to exceed institutional upper limits of normal, or creatinine clearance > or equal to 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

11) Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

12) There should be a four-week delay between the conclusion of radiation and the start of Gemcitabine, provided the acute effects of radiation treatment have resolved.

Exclusion Criteria:

1) Prior therapy with farnesyltransferase inhibitor or Gemcitabine for metastatic breast cancer.

2) Patients with leptomeningeal disease and/or brain metastasis.

3) No history of concomitant malignancy except for non-melanoma skin cancer or cervical cancer in situ or other malignancy treated curatively and no evidence of disease for at least five years.

4) Patients with peripheral neuropathy > or equal to grade 2.

5) Patients with symptomatic lymphangitic pulmonary metastases.

6) Patients who have had chemotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

7) Patients may not be receiving any other investigational agents.

8) History of allergic reactions attributed to compounds of similar chemical or biologic composition to Tipifarnib (R115777), or imidazole derivatives.

9) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

10) Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with Tipifarnib (R115777) or other agents administered during the study. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.

Links

Registration Number: NCT00100750
Study Information on Clinical Trials Registry (clinicaltrials.gov)