Carboplatin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Breast Cancer

University of Southampton

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Gemcitabine Hydrochloride; Drug: Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00470249

2005-005164-83 (EudraCT Number)

CDR0000542627

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving carboplatin together with gemcitabine works in treating patients with locally advanced or metastatic breast cancer.

Full description

OBJECTIVES:

Primary

• Determine the overall response rate in patients with anthracycline- and taxane-resistant locally advanced or metastatic breast cancer treated with dose-dense carboplatin and gemcitabine hydrochloride.

Secondary

• Determine the overall toxicity of this regimen in these patients.
• Determine the overall survival of patients treated with this regimen.
• Determine the time to disease progression in patients treated with this regimen.
• Determine the duration of response in patients treated with this regimen.
• Determine the time to treatment failure in patients treated with this regimen.

OUTLINE: This is a nonrandomized, open-label study.

Patients receive carboplatin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 150 minutes on day 2. Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for 2 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Enrollment: 5 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• DISEASE CHARACTERISTICS: histologically confirmed breast cancer, locally advanced or metastatic disease, recurrent or refractory disease, histological or cytological confirmation required for recurrence in a solitary site
• Must have received prior anthracycline and taxane as neoadjuvant, adjuvant, or metastatic therapy
• At least 1 measurable site of disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• Palpable disease allowed, Lesions that have been irradiated in the advanced setting cannot be included as sites of measurable disease
• No nonmeasurable disease only, including the following:
• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural or pericardial effusion
• Inflammatory breast disease
• Lymphangitic pulmonary disease
• Abdominal masses that are not confirmed and followed by imaging techniques
• Cystic lesions
• No HER2-positive disease, defined as 3+ by IHC OR positive by FISH or chromogenic in situ hybridization
• Hormone receptor status not specified
• PATIENT CHARACTERISTICS:
• Male or female, Menopausal status not specified, ECOG performance status 0-1, Estimated life expectancy ≥ 12 weeks, Not pregnant or nursing, fertile patients must use effective contraception during and for 3 months after completion of study therapy
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL
• ALT or AST < 2.5 times upper limit of normal (ULN)
• Bilirubin normal
• Alkaline phosphatase ≤ 2.5 times ULN
• Creatinine ≤ 1.25 times ULN OR creatinine clearance > 40 mL/min
• Calcium ≤ 1.2 times ULN
• No concurrent serious medical or psychiatric illness, including any serious active infection incompatible with the study
• No other primary malignancy except carcinoma in situ of the cervix, adequately treated nonmelanomatous skin cancer, or any other malignancy previously treated ≥ 5 years ago with no evidence of recurrence
• No peripheral neuropathy ≥ grade 2
• PRIOR CONCURRENT THERAPY (See Disease Characteristics):
• Recovered from prior chemotherapy
• Prior hormonal therapy or immunotherapy allowed
• Antitumoral hormonal therapy must be discontinued prior to study entry
• More than 4 weeks since prior radiotherapy and recovered
• No prior radiotherapy to the whole pelvis or to ≥ 25% of the bone marrow
• No prior gemcitabine hydrochloride, cisplatin, or carboplatin
• No other cytotoxic chemotherapy for 21 days before and for 14 days after completion of study therapy
• More than 30 days since prior treatment with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry
• Bisphosphonate therapy may not be initiated or discontinued within 4 weeks of study entry
• No more than 1 prior course of chemotherapy for metastatic disease
• Prior chemotherapy in the adjuvant setting allowed
• Concurrent palliative radiotherapy to existing painful lesions (soft tissue or bone) allowed
• New bone pain requiring radiotherapy > 4 weeks after first study treatment considered disease progression
• New pain in a soft tissue lesion without other objective changes may be irradiated provided ≥ 1 other site of nonirradiated measurable disease exists
• No other concurrent anticancer treatment
• No concurrent tamoxifen citrate, aromatase inhibitors, or progestagens

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Patients with (HER-2)-negative and anthracycline- and taxane-resistant

Experimental group

Description:

Patients with human epidermal growth factor 2 (HER-2)-negative locally advanced or metastatic breast cancer that was anthracycline- and taxane-resistant

Treatment:

Drug: Gemcitabine Hydrochloride

Drug: Carboplatin