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

NCT00437749 | Terminated Phase 3

• 1 other identifier: CBA-TP0301
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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

Conditions

Non-Small Cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall Survival

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

Secondary Outcomes (3)

• Time to Progression

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

• Response Rates

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

• Progression Free Survival

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

Study Arms (2)

CBT-1

ACTIVE COMPARATOR

Drug: CBT-1

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

CBT-1 DRUG

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

CBT-1

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CBA Research: lead

Study Sites (1)

Arizona Clinical Research Center

Tuscon, Arizona, 85715, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Robert Oldham, MD

  CBA Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2007
• First Posted: February 21, 2007
• Study Start: August 1, 2001
• Primary Completion: July 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 9, 2011

Record last verified: 2011-09

Locations

US (1)