LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: gemcitabine hydrochloride; Drug: pemetrexed disodium	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	59 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer
Study Start Date :	December 2000
Actual Primary Completion Date :	March 2004
Actual Study Completion Date :	May 2008

Arms and Interventions

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Arm

Intervention/treatment

Experimental: gemcitabine + pemetrexed; 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

Outcome Measures

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Primary Outcome Measures :

1. time to progression [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :

1. overall survival [ Time Frame: Up to 5 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

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  Show 24 Study Locations

Sponsors and Collaborators

Alliance for Clinical Trials in Oncology

National Cancer Institute (NCI)

Investigators

Study Chair:	Alex A. Adjei, MD, PhD	Mayo Clinic

More Information

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Publications of Results:

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. Epub 2005 Nov 22.

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.

Responsible Party:	Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:	NCT00006007 History of Changes
Other Study ID Numbers:	NCCTG-983253; NCI-2012-02348 ( Registry Identifier: CTRP (Clinical Trials Reporting System) ); CDR0000068015 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted:	January 27, 2003
Last Update Posted:	December 7, 2016
Last Verified:	December 2016

Keywords provided by Alliance for Clinical Trials in Oncology:

stage IV breast cancer; recurrent breast cancer

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Gemcitabine; Pemetrexed; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action	Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors