LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer

NCT00006007 | Completed Phase 2 DMC

• 3 other identifiers: NCCTG-983253NCI-2012-02348CDR0000068015
• Study Type: interventional
• Target: 59
• Locations: 2 countries
• Sites: 24

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Outcome Measures

Primary Outcomes (1)

• time to progression

  Up to 5 years

Secondary Outcomes (1)

• overall survival

  Up to 5 years

Study Arms (1)

gemcitabine + pemetrexed

EXPERIMENTAL

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.

Drug: gemcitabine hydrochloride; Drug: pemetrexed disodium

Interventions

gemcitabine hydrochloride DRUG

gemcitabine + pemetrexed

pemetrexed disodium DRUG

gemcitabine + pemetrexed

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (24)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Health Plaza

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Altru Health Systems

Grand Forks, North Dakota, 58201, United States

Location

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, 43623-3456, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (2)

• Ma CX, Steen P, Rowland KM, Niedringhaus RD, Fitch TR, Kugler JW, Hillman DW, Perez EA, Ingle JN, Adjei AA. A phase II trial of a combination of pemetrexed and gemcitabine in patients with metastatic breast cancer: an NCCTG study. Ann Oncol. 2006 Feb;17(2):226-31. doi: 10.1093/annonc/mdj054. Epub 2005 Nov 22.

  PMID: 16303865 RESULT

• Ma CX, Steen P, Rowland KM, et al.: A phase II study of a combination of pemetrexed (Pem) and gemcitabine (Gem) in patients with metastatic breast cancer (MBC): an NCCTG study. [Abstract] J Clin Oncol 22 (Suppl 14): A-639, 36s, 2004.

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gemcitabine; Pemetrexed

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Alex A. Adjei, MD, PhD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: January 27, 2003
• Study Start: December 1, 2000
• Primary Completion: March 1, 2004
• Study Completion: May 1, 2008
• Last Updated: December 7, 2016

Record last verified: 2016-12

Locations

US (23); CA (1)