Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer

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Primary Purpose

Status

Unknown status

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

docetaxel

ifosfamide

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed metastatic breast cancer Bidimensionally measurable lesions The following are not considered measurable: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Disease progression after hormonal therapy allowed provided at least 1 month since last therapeutic manipulation No CNS metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 21 to 75 Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 OR Zubrod 0-2 Life expectancy: More than 12 weeks Hematopoietic: WBC at least 4,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 11 g/dL Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGOT no greater than 1.25 times ULN Renal: Creatinine clearance at least 60 mL/min Cardiovascular: No history of congestive heart failure No myocardial infarction within the past 6 months No active ischemic heart disease No uncontrolled hypertension Other: Not pregnant No other prior or concurrent malignancy except properly treated basal cell skin cancer or carcinoma in situ of the cervix No other medical or psychiatric diseases that would preclude study No geographical situation that would preclude study No history of alcohol abuse PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior adjuvant chemotherapy including ifosfamide or docetaxel No prior systemic chemotherapy for metastatic breast cancer Endocrine therapy: See Disease Characteristics No concurrent corticoids, gestagens, or androgens unless strictly indicated Radiotherapy: Not specified Surgery: Not specified Other: No concurrent drinks containing caffeine or alcohol

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Time to treatment failure

Duration of response

Survival

Toxicity as assessed by CTC version 2.0

Quality of life as assessed by Schipper's Functional Living Index - Cancer

Full Information

NCT ID

NCT00026078

First Posted

November 9, 2001

Last Updated

August 6, 2013

Sponsor

Grupo Oncologico Cooperativo del Sur

1. Study Identification

Unique Protocol Identification Number

NCT00026078

Brief Title

Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer

Official Title

Docetaxel (DTX) - Ifosfamide (IFX) As First Line Chemotherapy In Metastatic Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

November 2006

Overall Recruitment Status

Unknown status

Study Start Date

March 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Grupo Oncologico Cooperativo del Sur

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of docetaxel and ifosfamide in treating women who have metastatic breast cancer.

Detailed Description

OBJECTIVES: Determine the efficacy of docetaxel and ifosfamide as first-line chemotherapy in women with metastatic breast cancer. Determine the response rate and duration of response of patients treated with this regimen. Determine the time to treatment failure and survival of patients treated with this regimen. Determine the toxicity of this regimen in these patients. Determine the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour on day 1 and ifosfamide IV over 1 hour (beginning 1 hour after docetaxel infusion) on days 1-3. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every month during study, and then every 3 months after completion of study. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 15-42 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

stage IV breast cancer, recurrent breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

docetaxel

Intervention Type

Drug

Intervention Name(s)

ifosfamide

Primary Outcome Measure Information:

Title

Response rate

Secondary Outcome Measure Information:

Title

Time to treatment failure

Title

Duration of response

Title

Survival

Title

Toxicity as assessed by CTC version 2.0

Title

Quality of life as assessed by Schipper's Functional Living Index - Cancer

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic breast cancer Bidimensionally measurable lesions The following are not considered measurable: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Disease progression after hormonal therapy allowed provided at least 1 month since last therapeutic manipulation No CNS metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 21 to 75 Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 OR Zubrod 0-2 Life expectancy: More than 12 weeks Hematopoietic: WBC at least 4,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 11 g/dL Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGOT no greater than 1.25 times ULN Renal: Creatinine clearance at least 60 mL/min Cardiovascular: No history of congestive heart failure No myocardial infarction within the past 6 months No active ischemic heart disease No uncontrolled hypertension Other: Not pregnant No other prior or concurrent malignancy except properly treated basal cell skin cancer or carcinoma in situ of the cervix No other medical or psychiatric diseases that would preclude study No geographical situation that would preclude study No history of alcohol abuse PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior adjuvant chemotherapy including ifosfamide or docetaxel No prior systemic chemotherapy for metastatic breast cancer Endocrine therapy: See Disease Characteristics No concurrent corticoids, gestagens, or androgens unless strictly indicated Radiotherapy: Not specified Surgery: Not specified Other: No concurrent drinks containing caffeine or alcohol

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bernardo A. Leone, MD

Organizational Affiliation

Unidad Oncologica Del Neuquen

Official's Role

Study Chair

Facility Information:

Facility Name

Grupo Oncologico Cooperativo del Sur

City

Bahia Blanca

State/Province

Buenos Aires

ZIP/Postal Code

8000

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Juan Eduardo Perez, MD

Phone

54-291-452-5667

Email

jperez@criba.edu.ar

Facility Name

Policlinica Privada Instituto De Medicina Nuclear

City

Bahia Blanca

State/Province

Buenos Aires

ZIP/Postal Code

8000

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alberto Omar Romero, MD

Phone

54-291-453-9848

Email

gocsbhb@bvconline.com.ar

Facility Name

St. Joseph Medical Center

City

Gonnet

State/Province

Buenos Aires

ZIP/Postal Code

1987 MB

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sergio Grasso, MD

Phone

54-221-4845088

Facility Name

Sanatorio Santa Rosa S.R.L.

City

Santa Rosa

State/Province

La Pampa

ZIP/Postal Code

6300

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eduardo Heriberto Ortiz, MD

Phone

54-2954-29-715

Facility Name

C.R I O.

City

Mar del Plata

ZIP/Postal Code

7600

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ricardo L. Rodriguez, MD

Phone

54-223-479-3283

Email

ricrodri@copetel.com.ar

Facility Name

Unidad Oncologica Del Neuquen

City

Neuquen

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bernardo A. Leone, MD

Phone

54-299-448-5247

Email

bleone@satlink.com

Facility Name

Centro Oncologico Tres Arroyos

City

Tres Arroyos

ZIP/Postal Code

7500

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Ester Dominguez, MD

Phone

0983-33450

Email

medominquez@3net.com.ar

Facility Name

Centro Medico Nacional de Occidente

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

4430

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gilberto Morgan Villela, MD

Phone

523-641-5081

Breast Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial