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Phase 3, Randomized, Double-Blind, Placebo-controlled Study of CBT-1 and Paclitaxel/Carboplatin in Patients With Inoperable Non-Small Cell Lung Cancer

Phase 3
18 Years
Not Enrolling
Non-Small Cell Lung Cancer

Thank you

Trial Information

Phase 3, Randomized, Double-Blind, Placebo-controlled Study of CBT-1 and Paclitaxel/Carboplatin in Patients With Inoperable Non-Small Cell Lung Cancer

Lung cancer has the highest incidence and prevalence among cancers in the world and remains
the leading cause of cancer-related deaths in Western countries. One-year survival of
patients with best supportive care remains low. Non-small-cell lung cancer accounts for
almost 85% of all lung cancer cases. Approximately 70% of patients have locally advanced or
metastatic disease at presentation and are not candidates for surgery.

Inclusion Criteria:

- histological confirmed diagnosis of NSCLC

- advanced inoperable NSCLC

- have adequate renal function, serum creatinine <2.0 mg/dL or 24 hour creatinine
clearance > 50mL/minute

- have adequate liver function defined as SGOT <4 times the upper limit of normal (ULN)
and bilirubin <2.0 mg/dL

- have calcium <11.0 mg/dL and albumin >2.0g/dL

- have adequate bone marrow reserve defined as granulocyte count >1,500/mm3, hemoglobin
>10.0 g/dL and platelets >100,000/mm3

- if female and of child-bearing potential, agree to use one of the following methods
of birth control: oral contraceptives, barrier with spermicide, intrauterine
progesterone contraceptive system, levonorgestrel implant, medroxyprogesterone
acetate contraceptive injection, complete abstinence from sexual intercourse

Exclusion Criteria:

- have previously received taxanes, platinums, vinca alkaloids, anthracyclines,
epipodophyllotoxins or CBT-1

- have known or suspected hypersensitivity to platinum containing compounds, taxanes,
polyoxyethylated castor oil, or mannitol

- have significant central nervous system disease, including history of seizures within
last 3 months or psychiatric history which would impair the ability to give informed
consent or prevent compliance with protocol requirements

- be eligible for curative surgery or radiotherapy.

- must not have a diagnosis and/or treatment in the past 5 years of any malignancy
other than NSCLC or basal cell carcinoma of the skin

- be pregnant or nursing

- have a history of significant coronary artery disease, cardiac arrhythmias requiring
treatment, history of other cardiac disease or other cardiac anomalies determined by
ECG which in the judgment of the investigator would compromise the patient's ability
to tolerate the therapy

- have ongoing serious infections that require parenteral antibiotics

- have clinically significant bleeding disorders

- have solid organ allograft

- have significant intercurrent disease

- have bleeding peptic ulcer disease

- have participated in any experimental study within 2 months preceding enrollment

- be using a medication that could interact adversely with CBT-1, paclitaxel, or
carboplatin. Medications include:aminoglycoside antibiotics, Prilosec, Losec, Zantac

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

every month for first 6 months off study, then every 2-3 months for the next year, then every 6 months thereafter

Safety Issue:


Principal Investigator

Robert Oldham, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CBA Research


United States: Food and Drug Administration

Study ID:




Start Date:

August 2001

Completion Date:

November 2010

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non small cell lung cancer
  • Advanced
  • Inoperable
  • taxanes
  • carboplatin
  • multi-drug resistance
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Arizona Clinical Research Center Tucson, Arizona  85712