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A Phase I/II Study Of NB1011 Administered Intravenously Daily For 5 Days Every 4 Weeks In Fluoropyrimidine-Resistant Metastatic Or Relapsed Colorectal Cancers

Phase 1/Phase 2
18 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

A Phase I/II Study Of NB1011 Administered Intravenously Daily For 5 Days Every 4 Weeks In Fluoropyrimidine-Resistant Metastatic Or Relapsed Colorectal Cancers


- 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

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.

Inclusion Criteria


- 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



- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- At least 3 months


- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- 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


- Creatinine less than 1.5 mg/dL OR

- Creatinine clearance greater than 50 mL/min


- 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


Biologic therapy:

- Not specified


- See Disease Characteristics

- Recovered from prior anticancer chemotherapy

- No concurrent fluoropyrimidine-based or thymidylate synthase inhibitor agents

Endocrine therapy:

- Not specified


- Recovered from prior anticancer radiotherapy

- No concurrent radiotherapy except palliative radiotherapy (to control a fracture or
pain) provided index lesions are not involved


- Recovered from prior anticancer surgery


- At least 30 days since prior investigational agents

- No other concurrent anticancer therapy

- No concurrent disulfiram

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Mark D. Pegram, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 2001

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • Colorectal Neoplasms



Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804