NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00031616
• Other study ID #: CDR0000069205
• Secondary ID: NB-1011-1001NCI-
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: March 8, 2002
• Last updated: December 17, 2013
• Start date: December 2001

Study information

• Verified date: April 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• brivudine phosphoramidate

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
NewBiotics

Country where clinical trial is conducted

United States,