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NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
brivudine phosphoramidate
Sponsored by
NewBiotics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC/Norris Comprehensive Cancer Center and Hospital
  • Jonsson Comprehensive Cancer Center, UCLA

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 8, 2002
Last Updated
December 17, 2013
Sponsor
NewBiotics
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1. Study Identification

Unique Protocol Identification Number
NCT00031616
Brief Title
NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Official Title
A Phase I/II Study Of NB1011 Administered Intravenously Daily For 5 Days Every 4 Weeks In Fluoropyrimidine-Resistant Metastatic Or Relapsed Colorectal Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2004
Overall Recruitment Status
Unknown status
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
NewBiotics

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
brivudine phosphoramidate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark D. Pegram, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

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NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer

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