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Docetaxel and Carboplatin in Treating Women With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00005963
Recruitment Status : Completed
First Posted : December 23, 2003
Last Update Posted : December 7, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in treating women who have metastatic breast cancer.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: carboplatin Drug: docetaxel Phase 2

Detailed Description:

OBJECTIVES: I. Determine the anti-tumor activity of docetaxel and carboplatin in women with metastatic adenocarcinoma of the breast. II. Determine the objective response rate, time to progression, and survival in patients treated with this regimen. III. Determine the toxic effects of this regimen in these patients. IV. Assess the common functional polymorphisms in genes involved in chemotherapeutic response to improve prediction of clinical outcomes and provide insight into the potential for genotype-specific drug dosage.

OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease (SD), partial response (PR), or complete response (CR) may receive 4 additional courses past SD, PR, or CR. Patients are followed every 6 months for 2 years and then annually for 3 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Docetaxel and Carboplatin as First-Line Therapy for Metastatic Breast Cancer
Study Start Date : November 2000
Actual Primary Completion Date : October 2002
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: docetaxel + carboplatin
This is a multicenter study. Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease (SD), partial response (PR), or complete response (CR) may receive 4 additional courses past SD, PR, or CR. Patients are followed every 6 months for 2 years and then annually for 3 years.
Drug: carboplatin
Drug: docetaxel



Primary Outcome Measures :
  1. objective response rate [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. time to progression [ Time Frame: Up to 5 years ]
  2. survival [ Time Frame: Up to 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven metastatic adenocarcinoma of the breast Measurable disease At least 20 mm in at least 1 dimension Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT/SGPT no greater than 2.5 times ULN Alkaline phosphatase no greater than ULN OR SGOT/SGPT no greater than ULN Alkaline phosphatase no greater than 4 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No myocardial infarction within the past 6 months No congestive heart failure No unstable angina No clinically significant pericardial effusion or arrhythmia Other: No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No active unresolved infection No prior hypersensitivity reaction to docetaxel No grade 2 or greater sensory or motor neuropathy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent prophylactic filgrastim (G-CSF) during the first course of study therapy Chemotherapy: No prior chemotherapy for metastatic disease Prior adjuvant chemotherapy allowed More than 1 year since prior paclitaxel, docetaxel, cisplatin, or carboplatin No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy to breast, chest wall, or axilla No prior radiotherapy to greater than 30% of bone marrow No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery and recovered Other: More than 7 days since prior IV antibiotics No concurrent experimental drugs


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005963


Locations
Show Show 21 study locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Edith A. Perez, MD Mayo Clinic
Publications of Results:
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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00005963    
Other Study ID Numbers: NCCTG-N9932
CDR0000067945 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2012-02341 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
First Posted: December 23, 2003    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Keywords provided by Alliance for Clinical Trials in Oncology:
stage IV breast cancer
recurrent breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carboplatin
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action