Clinical Trials /

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

NCT00470249

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Carboplatin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Breast Cancer
  • Official Title: A Phase II Study of Carboplatin in Combination With Gemcitabine as a Dose Dense Schedule in Patients With Locally Advanced or Metastatic Breast Cancer That Are Resistant to Anthracyclines & Taxanes

Clinical Trial IDs

  • ORG STUDY ID: CDR0000542627
  • SECONDARY ID: USCTU-BR2056-GemCarbo
  • SECONDARY ID: LILLY-USCTU-BR2056-GemCarbo
  • SECONDARY ID: EUDRACT-2005-005164-83
  • SECONDARY ID: EU-20728
  • SECONDARY ID: USCTU-CAN-0438
  • NCT ID: NCT00470249

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
carboplatin
gemcitabine hydrochloride

Purpose

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.

Detailed 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.
    

Trial Arms

NameTypeDescriptionInterventions

Eligibility 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

          -  Measurable disease*

               -  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 NOTE: *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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate (complete or partial response)
Time Frame:
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall toxicity as assessed by NCI CTCAE v3.0
Time Frame:
Safety Issue:
Description:
Measure:Overall survival
Time Frame:
Safety Issue:
Description:
Measure:Time to disease progression
Time Frame:
Safety Issue:
Description:
Measure:Duration of response
Time Frame:
Safety Issue:
Description:
Measure:Time to treatment failure
Time Frame:
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Unknown status
Lead Sponsor:University Hospital Southampton NHS Foundation Trust

Trial Keywords

  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • male breast cancer
  • stage IIIA breast cancer

Last Updated

August 1, 2009