NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer
NCT ID: NCT00031616
Last Updated: 2013-12-18
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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UNKNOWN
PHASE1/PHASE2
INTERVENTIONAL
2001-12-31
Brief Summary
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PURPOSE: Phase I/II trial to study the effectiveness of NB1011 in treating patients who have metastatic or recurrent colorectal cancer that has not responded to previous treatment.
Detailed Description
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* Determine the maximum tolerated dose of NB1011 in patients with fluoropyrimidine-resistant metastatic or recurrent colorectal cancer.
* Determine the safety and toxic effects of this drug in these patients.
* Determine the pharmacokinetics of this drug in these patients.
* Determine the efficacy of this drug in these patients.
OUTLINE: This is a phase I dose-escalation study followed by a phase II study.
* Phase I: Patients receive NB1011 IV over 1 hour on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of NB1011 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
* Phase II: Additional patients receive NB1011 at the MTD as in phase I. Patients are followed at day 30 and then for 5 months.
PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for the phase I portion of this study. A total of 15-25 patients will be accrued for the phase II portion of this study.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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brivudine phosphoramidate
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed metastatic or recurrent colorectal adenocarcinoma that has progressed during or within 6 months of fluoropyrimidine-based therapy
* Prior treatment with irinotecan with or without fluorouracil
* Evaluable or measurable disease
* Uni-dimensionally measurable disease allowed provided CEA is at least 2 times the upper limit of normal
* No meningeal or CNS metastases or carcinomatous meningitis
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 70-100%
Life expectancy:
* At least 3 months
Hematopoietic:
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin less than 1.5 mg/dL (regardless of liver metastases)
* AST and ALT less than 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases present)
* PT and INR normal
* PTT normal
Renal:
* Creatinine less than 1.5 mg/dL OR
* Creatinine clearance greater than 50 mL/min
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No known hypersensitivity to NB1011 or any excipient or vehicle in its formulation
* No active or uncontrolled serious bacterial, viral, fungal, or parasitic infection
* No prior or concurrent alcohol abuse or dependency
* No other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No concurrent medical or psychological condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* Recovered from prior anticancer chemotherapy
* No concurrent fluoropyrimidine-based or thymidylate synthase inhibitor agents
Endocrine therapy:
* Not specified
Radiotherapy:
* Recovered from prior anticancer radiotherapy
* No concurrent radiotherapy except palliative radiotherapy (to control a fracture or pain) provided index lesions are not involved
Surgery:
* Recovered from prior anticancer surgery
Other:
* At least 30 days since prior investigational agents
* No other concurrent anticancer therapy
* No concurrent disulfiram
18 Years
ALL
No
Sponsors
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NewBiotics
INDUSTRY
Principal Investigators
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Mark D. Pegram, MD
Role: STUDY_CHAIR
Jonsson Comprehensive Cancer Center
Locations
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USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Countries
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Other Identifiers
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NB-1011-1001
Identifier Type: -
Identifier Source: secondary_id
NCI-V01-1689
Identifier Type: -
Identifier Source: secondary_id
CDR0000069205
Identifier Type: -
Identifier Source: org_study_id