- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00031616
NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer
A Phase I/II Study Of NB1011 Administered Intravenously Daily For 5 Days Every 4 Weeks In Fluoropyrimidine-Resistant Metastatic Or Relapsed Colorectal Cancers
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- 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.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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-
California
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, United States, 90033
- USC/Norris Comprehensive Cancer Center and Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Brivudine
- Phosphoramidic acid
Other Study ID Numbers
- CDR0000069205
- NB-1011-1001
- NCI-V01-1689
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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