LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer
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| ClinicalTrials.gov Identifier: NCT00006007 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : December 7, 2016
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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 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 59 participants |
| Allocation: | N/A |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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 |
- time to progression [ Time Frame: Up to 5 years ]
- overall survival [ Time Frame: Up to 5 years ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed breast cancer with clinical evidence of metastatic disease
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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
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No active CNS metastases
- Treated CNS metastasis that has ben stable for at least 8 weeks allowed
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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
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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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006007
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| Study Chair: | Alex A. Adjei, MD, PhD | Mayo Clinic |
| Responsible Party: | Alliance for Clinical Trials in Oncology |
| ClinicalTrials.gov Identifier: | NCT00006007 |
| 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 Key Record Dates |
| Last Update Posted: | December 7, 2016 |
| Last Verified: | December 2016 |
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stage IV breast cancer recurrent breast cancer |
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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 |