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NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00031616
Recruitment Status : Unknown
Verified April 2004 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: brivudine phosphoramidate Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
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 Start Date : December 2001

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031616


Locations
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United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
NewBiotics
Investigators
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Study Chair: Mark D. Pegram, MD Jonsson Comprehensive Cancer Center

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ClinicalTrials.gov Identifier: NCT00031616     History of Changes
Other Study ID Numbers: CDR0000069205
NB-1011-1001
NCI-V01-1689
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: April 2004

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Phosphoramidic acid
Brivudine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents