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

Primary Purpose

Non-Small Cell Lung Cancer

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

CBT-1

Placebo

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Non small cell lung cancer, Advanced, Inoperable, taxanes, carboplatin, multi-drug resistance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arizona Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CBT-1

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Time to Progression

Response Rates

Progression Free Survival

Full Information

NCT ID

NCT00437749

First Posted

February 19, 2007

Last Updated

September 8, 2011

Sponsor

CBA Research

1. Study Identification

Unique Protocol Identification Number

NCT00437749

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Terminated

Why Stopped

slow accrual rate; interim accrual objective met

Study Start Date

August 2001 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CBA Research

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small Cell Lung Cancer

Keywords

Non small cell lung cancer, Advanced, Inoperable, taxanes, carboplatin, multi-drug resistance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

214 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBT-1

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

CBT-1

Intervention Description

(50 mg caps) 500 mg/m2/day x 7 + paclitaxel 135 mg/m2 + carboplatin AUC 6

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

(50 mg caps) 500 mg/m2/day x 7 + paclitaxel 135 mg/m2 + carboplatin AUC 6

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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.

Title

Response Rates

Time Frame

every 2-3 months following completion of therapy until disease progression

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Oldham, MD

Organizational Affiliation

CBA Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Arizona Clinical Research Center

City

Tuscon

State/Province

Arizona

ZIP/Postal Code

85715

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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