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LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer

A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00006007
Enrollment
59
Registered
2003-01-27
Start date
2000-12-31
Completion date
2008-05-31
Last updated
2016-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage IV breast cancer, recurrent breast cancer

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 drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining LY231514 plus gemcitabine in treating women who have metastatic breast cancer.

Detailed description

OBJECTIVES: * Assess the antitumor activity of pemetrexed disodium in combination with gemcitabine in the treatment of women with metastatic breast cancer who have received an anthracycline and a taxane in the adjuvant and/or metastatic setting and no more than 1 chemotherapy regimen for metastatic disease (unless these were a taxane and anthracycline). * Determine the toxicity of this regimen in this patient population. * Determine time to progression and overall survival of these patients receiving this regimen. OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8. pemetrexed disodium IV is administered over 10 minutes 90 minutes following gemcitabine on day 8. Treatment continues every 21 days for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients achieving a complete response receive 2 additional courses. Patients are followed every 3 months for 5 years. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1 year.

Interventions

DRUGgemcitabine hydrochloride
DRUGpemetrexed disodium

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed breast cancer with clinical evidence of metastatic disease * Bidimensionally measurable disease * If bisphosphonates used, must have measurable disease site other than bone * No bone only disease * Must have received a prior anthracycline and taxane in the adjuvant and/or metastatic setting * No clinically significant pericardial effusions, pleural effusions, or ascites unless they can be drained * No active CNS metastases * Treated CNS metastasis that has ben stable for at least 8 weeks allowed * 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: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST no greater than 3 times ULN (5 times ULN if liver metastases) * Albumin at least 3.0 g/dL Renal: * Creatinine clearance at least 45 mL/min Cardiovascular: * No New York Heart Association class III or IV heart disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to take folic acid and cyanocobalamin (vitamin B12) supplements * Body surface area less than 3 m\^2 * No uncontrolled infection * No chronic debilitating disease * No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinomas PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy * At least 4 weeks since prior genetic therapy * No concurrent immunomodulating agents Chemotherapy: * See Disease Characteristics * No more than 3 prior chemotherapy regimens including adjuvant therapy * No more than 1 prior chemotherapy regimen for metastatic disease unless these were a taxane and anthracycline * At least 4 weeks since prior chemotherapy * No prior gemcitabine and/or pemetrexed disodium * No other concurrent cytostatic or cytotoxic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy * No prior radiotherapy to greater than 25% of bone marrow * No prior strontium chloride Sr 89 * No concurrent radiotherapy Surgery: * At least 4 weeks since prior major surgery Other: * No aspirin or nonsteroidal antiinflammatory agents 2 days before, the day of, and for 2 days after pemetrexed disodium administration (5 days before for long acting agents such as naproxen, piroxicam, diflunisal, or nabumetone)

Design outcomes

Primary

MeasureTime frame
time to progressionUp to 5 years

Secondary

MeasureTime frame
overall survivalUp to 5 years

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026