Los Angeles, California 90095

  • Colorectal Cancer

Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

CDR0000069205


NCT ID:

NCT00031616


Secondary ID:

NB-1011-1001


Study Acronym:


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


Overall Status:

Active, not recruiting


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Mark D. Pegram, MD
Study Chair
Jonsson Comprehensive Cancer Center

Study Dates

Start Date:December 2001
Verification Date:April 2004
Last Changed Date:December 17, 2013
First Received Date:March 8, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:brivudine phosphoramidate

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:NewBiotics

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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