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:
CBA Research
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 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:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 16, 2013