Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

TERMINATED

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

Lead Sponsor:

University of Southampton

Conditions:

Breast Cancer

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief Summary

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. Giv...

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 ge...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 15 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 3 2008

    Estimated Enrollment :

    5 Patients enrolled

    Trial Details

    Trial ID

    NCT00470249

    Start Date

    July 15 2006

    End Date

    November 3 2008

    Last Update

    February 1 2021

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Royal Bournemouth Hospital

    Bournemouth, England, United Kingdom, BH7 7DW

    2

    Portsmouth Oncology Centre at Saint Mary's Hospital

    Portsmouth, England, United Kingdom, PO3 6AD

    3

    Southampton General Hospital

    Southampton, England, United Kingdom, SO16 6YD