NCT00031616

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2002

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

December 18, 2013

Status Verified

April 1, 2004

First QC Date

March 8, 2002

Last Update Submit

December 17, 2013

Conditions

Colorectal Cancer

Keywords

stage IV colon cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal canceradenocarcinoma of the colonadenocarcinoma of the rectum

Interventions

brivudine phosphoramidateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Mark D. Pegram, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 8, 2002

First Posted

January 27, 2003

Study Start

December 1, 2001

Last Updated

December 18, 2013

Record last verified: 2004-04

Locations

US(2)