Study of Motexafin Gadolinium and Docetaxel for Advanced Solid Tumors
NCT ID: NCT00080041
Last Updated: 2007-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Motexafin Gadolinium Injection
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed diagnosis of cancer (i.e., Unresectable locally advanced or metastatic non-small-cell lung carcinoma (NSCLC) that had progressed during or after one or more chemotherapy regimens; Metastatic breast cancer; Hormone-refractory prostate cancer; Recurrent or refractory ovarian cancer; Sarcoma)
* ECOG performance status score either 0 or 1
* Willing and able to provide written informed consent
Exclusion Criteria
* Absolute neutrophil count \< 2000/µL
* Platelet count \< 100,00/µL
* AST or ALT \> 1.5 x the upper limit of normal
* Alkaline phosphatase \> 5 x the upper limit of normal
* Bilirubin \> ULN
* Creatinine \> 2.0 mg/dL
and
* Peripheral neuropathy NCI CTC Grade 3 or higher
* Chemotherapy, radiation therapy, immunotherapy, or systemic biologic
* anticancer therapy within 21 days before beginning study treatment
* Known history of brain metastases or spinal cord compression
* Uncontrolled hypertension
* Myocardial infarction within 6 months before beginning study treatment
* Unstable angina pectoris, uncontrolled congestive heart failure, or uncontrolled serious arrhythmias
* Known sensitivity to or intolerable adverse effects from taxanes or polysorbate 80
* Known history of porphyria (testing not required at screening)
* Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not required at screening)
* Known history of HIV infection (testing not required at screening)
* Female who is pregnant or lactating (pregnancy test is required for all female patients of childbearing potential)
* Female of childbearing potential or sexually active male unwilling to use adequate contraceptive protection
* Physical or mental condition that makes patient unable to complete specified follow-up assessments
18 Years
ALL
No
Sponsors
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Pharmacyclics LLC.
INDUSTRY
Locations
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University of Rochester Cancer Center
Rochester, New York, United States
Countries
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Other Identifiers
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PCYC-0214
Identifier Type: -
Identifier Source: org_study_id