Trial record 2 of 2 for:    "Carotid body tumor"

A Study of CBT-1 and Paclitaxel With Carboplatin in Patients With Advanced Inoperable Non-small Cell Lung Cancer

This study has been terminated.
(slow accrual rate; interim accrual objective met)
Sponsor:
Information provided by (Responsible Party):
CBA Research
ClinicalTrials.gov Identifier:
NCT00437749
First received: February 19, 2007
Last updated: September 8, 2011
Last verified: September 2011
  Purpose

Multiple Drug Resistance is the phenomena whereby cells become resistant to a variety of drugs with different mechanisms of action. Drug resistance remains a significant impediment to successful cancer chemotherapy inhibitors have been developed and are currently in clinical trials. CBT-1 is a natural product currently in clinical trials as an inhibitor


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: CBT-1
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3, Randomized, Double-Blind, Placebo-controlled Study of CBT-1 and Paclitaxel/Carboplatin in Patients With Inoperable Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by CBA Research:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: every month for first 6 months off study, then every 2-3 months for the next year, then every 6 months thereafter ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to Progression [ Time Frame: each month for the first 6 months off study, then every 2-3 months for the next year, then every 6 months thereafter. ] [ Designated as safety issue: Yes ]
  • Response Rates [ Time Frame: every 2-3 months following completion of therapy until disease progression ] [ Designated as safety issue: Yes ]
  • Progression Free Survival [ Time Frame: every month for first 6 months off study, then every 2-3 months for next year, then every 6 months thereafter. ] [ Designated as safety issue: Yes ]

Enrollment: 214
Study Start Date: August 2001
Study Completion Date: November 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CBT-1 Drug: CBT-1
(50 mg caps) 500 mg/m2/day x 7 + paclitaxel 135 mg/m2 + carboplatin AUC 6
Placebo Comparator: Placebo Other: Placebo
(50 mg caps) 500 mg/m2/day x 7 + paclitaxel 135 mg/m2 + carboplatin AUC 6

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437749

Locations
United States, Arizona
Arizona Clinical Research Center
Tuscon, Arizona, United States, 85715
Sponsors and Collaborators
CBA Research
Investigators
Principal Investigator: Robert Oldham, MD CBA Research
  More Information

No publications provided

Responsible Party: CBA Research
ClinicalTrials.gov Identifier: NCT00437749     History of Changes
Other Study ID Numbers: CBA-TP0301
Study First Received: February 19, 2007
Last Updated: September 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by CBA Research:
Non small cell lung cancer
Advanced
Inoperable
taxanes
carboplatin
multi-drug resistance

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014