Status:
COMPLETED
Pemetrexed Disodium and Docetaxel in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells of by stopping them from dividing. Pemetrexed disodium m...
Detailed Description
OBJECTIVES: Primary * To determine the maximum-tolerated dose of the combination of pemetrexed disodium and docetaxel when administered on a day 1 and day 15 dosing schedule. Secondary * To specif...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of advanced or recurrent solid tumors
- Patients for whom docetaxel is considered appropriate anticancer therapy; docetaxel is currently approved for use in patients with the following solid tumors:
- Non-small cell lung (NSCLC)
- Breast
- Prostate
- Esophageal
- Head and neck
- Ovarian
- Gastric
- Measurable or non-measurable disease
- No squamous cell NSCLC
- Controlled brain metastases allowed
- Clinically stable with no signs of progression by MRI or CAT scan ≥ 60 days after treatment
- Patients must be asymptomatic with no steroid requirements
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 12 weeks
- WBC ≥ 3,000/mm\^3\*
- ANC ≥ 1,500/mm\^3\*
- Hemoglobin ≥ 9 g/dL
- Platelet count ≥ 100,000/mm\^3
- Total bilirubin normal
- AST, ALT, and alkaline phosphatase (AP) must meet one of the following criteria:
- AST or ALT ≤ 3\*\* times upper limit of normal (ULN) AND AP normal
- AST or ALT ≤ 1.5 times ULN AND AP ≤ 2.5 times ULN
- AST or ALT normal AND AP ≤ 5 times ULN
- Calculated creatinine clearance ≥ 45 mL/min OR GFR measured by Tc99m-DPTA serum clearance method
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
- Able to interrupt aspirin or other NSAIDs pre- and post- twice-monthly drug dosing
- Able to take folic acid, vitamin B12, or corticosteroids
- No uncontrolled serious active infections
- No pre-existing peripheral neuropathy \> grade 1
- No significant cardiac disease (i.e., uncontrolled high blood pressure, unstable angina, congestive heart failure within the past 6 months, LVEF \< normal, myocardial infarction within the past year, or serious cardiac arrhythmias requiring medication)
- No known severe hypersensitivity reaction to docetaxel or other drugs formulated in polysorbate 80 NOTE: \*No concurrent colony-stimulating factors to maintain these values
- NOTE: \*\*For patients with liver metastases, AST or ALT ≤ 5 times ULN AND AP normal
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Have received 0-1 prior systemic therapy regimens (prior adjuvant chemotherapy will be considered a prior systemic therapy regimen)
- At least 4 weeks since prior systemic anticancer therapy (6 weeks for mitomycin C and nitrosoureas)
- At least 2 weeks since prior radiotherapy and recovered from the side effects to ≤ grade 1
- At least 2 weeks since prior pleurodesis
- No concurrent radiotherapy
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01172028
Start Date
September 1 2005
End Date
July 1 2014
Last Update
December 3 2015
Active Locations (1)
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1
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024