Reducing Symptom Burden - Non Small Cell Lung Cancer (NSCLC)

NCT01048983 | Withdrawn Phase 1 DMC

• 3 other identifiers: 2008-0345R01 026582-26NCI-2012-01256
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical research study is to compare armodafinil, bupropion, curcumin, and minocycline when given alone or in combination to learn which is better for controlling symptoms, such as the side effects of chemoradiation, when given to treat lung cancer.

Conditions

Non Small Cell Lung Cancer

Keywords

Lung Cancer; NSCLC; Concurrent Chemoradiation Therapy; Side Effects; Armodafinil; Nuvigil; Bupropion; Wellbutrin; Wellbutrin SR; Zyban; Curcumin; Minocycline; Dynacin; Minocin; Minocin PAC; Myrac; Solodyn

Outcome Measures

Primary Outcomes (1)

• Combined AUC for Selected Symptoms

  10-weeks (+/- 4 days)

Study Arms (16)

Questionnaires and Phone Calls

OTHER

Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.

Behavioral: Telephone Questionnaire

Curcumin Only

ACTIVE COMPARATOR

Drug: Curcumin; Behavioral: Telephone Questionnaire

Armodafinil Only

ACTIVE COMPARATOR

Drug: Armodafinil; Behavioral: Telephone Questionnaire

Minocycline Only

ACTIVE COMPARATOR

Drug: Minocycline; Behavioral: Telephone Questionnaire

Bupropion Only

ACTIVE COMPARATOR

Drug: Bupropion; Behavioral: Telephone Questionnaire

Curcumin + Armodafinil

ACTIVE COMPARATOR

Drug: Armodafinil; Drug: Curcumin; Behavioral: Telephone Questionnaire

Curcumin + Minocycline

ACTIVE COMPARATOR

Drug: Minocycline; Drug: Curcumin; Behavioral: Telephone Questionnaire

Curcumin + Bupropion

ACTIVE COMPARATOR

Drug: Bupropion; Drug: Curcumin; Behavioral: Telephone Questionnaire

Armodafinil + Minocycline

ACTIVE COMPARATOR

Drug: Armodafinil; Drug: Minocycline; Behavioral: Telephone Questionnaire

Armodafinil + Bupropion

ACTIVE COMPARATOR

Drug: Armodafinil; Drug: Bupropion; Behavioral: Telephone Questionnaire

Minocycline + Buproprion

ACTIVE COMPARATOR

Drug: Bupropion; Drug: Minocycline; Behavioral: Telephone Questionnaire

Curcumin + Armodafinil + Minocycline

ACTIVE COMPARATOR

Drug: Armodafinil; Drug: Minocycline; Drug: Curcumin; Behavioral: Telephone Questionnaire

Curcumin + Armodafinil + Bupropion

ACTIVE COMPARATOR

Drug: Armodafinil; Drug: Bupropion; Drug: Curcumin; Behavioral: Telephone Questionnaire

Curcumin + Minocycline + Bupropion

ACTIVE COMPARATOR

Drug: Bupropion; Drug: Minocycline; Drug: Curcumin; Behavioral: Telephone Questionnaire

Armodafinil + Minocycline + Bupropion

ACTIVE COMPARATOR

Drug: Armodafinil; Drug: Bupropion; Drug: Minocycline; Behavioral: Telephone Questionnaire

Curcumin + Armodafinil + Minocycline + Bupropion

ACTIVE COMPARATOR

Drug: Armodafinil; Drug: Bupropion; Drug: Minocycline; Drug: Curcumin; Behavioral: Telephone Questionnaire

Interventions

Armodafinil DRUG

Initial Dose 150 mg once a day (50 mg and 100 mg oral tablets) for 10 weeks.

Also known as: Nuvigil, Modafinil

Armodafinil + Bupropion; Armodafinil + Minocycline; Armodafinil + Minocycline + Bupropion; Armodafinil Only; Curcumin + Armodafinil; Curcumin + Armodafinil + Bupropion; Curcumin + Armodafinil + Minocycline; Curcumin + Armodafinil + Minocycline + Bupropion

Bupropion DRUG

Initial Dose 100 mg two times a day (200 mg) for 10 weeks.

Also known as: Wellbutrin, Wellbutrin SR, Zyban

Armodafinil + Bupropion; Armodafinil + Minocycline + Bupropion; Bupropion Only; Curcumin + Armodafinil + Bupropion; Curcumin + Armodafinil + Minocycline + Bupropion; Curcumin + Bupropion; Curcumin + Minocycline + Bupropion; Minocycline + Buproprion

Minocycline DRUG

Initial Dose 100 mg two times a day (200 mg) for 10 weeks.

Also known as: Dynacin, Minocin, Minocin PAC, Myrac, Solodyn

Armodafinil + Minocycline; Armodafinil + Minocycline + Bupropion; Curcumin + Armodafinil + Minocycline; Curcumin + Armodafinil + Minocycline + Bupropion; Curcumin + Minocycline; Curcumin + Minocycline + Bupropion; Minocycline + Buproprion; Minocycline Only

Curcumin DRUG

Initial Dose 4 gm stick pack once a day (4 gm) for 10 weeks.

Curcumin + Armodafinil; Curcumin + Armodafinil + Bupropion; Curcumin + Armodafinil + Minocycline; Curcumin + Armodafinil + Minocycline + Bupropion; Curcumin + Bupropion; Curcumin + Minocycline; Curcumin + Minocycline + Bupropion; Curcumin Only

Telephone Questionnaire BEHAVIORAL

Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.

Also known as: Survey

Armodafinil + Bupropion; Armodafinil + Minocycline; Armodafinil + Minocycline + Bupropion; Armodafinil Only; Bupropion Only; Curcumin + Armodafinil; Curcumin + Armodafinil + Bupropion; Curcumin + Armodafinil + Minocycline; Curcumin + Armodafinil + Minocycline + Bupropion; Curcumin + Bupropion; Curcumin + Minocycline; Curcumin + Minocycline + Bupropion; Curcumin Only; Minocycline + Buproprion; Minocycline Only; Questionnaires and Phone Calls

Eligibility Criteria

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

You may qualify if:

• Patients with a pathologically proven diagnosis of unresectable Non-small-cell lung carcinoma (NSCLC) and consented to concurrent chemoradiation therapy in MD Anderson Cancer Center (MDACC).
• Patients \>= 18 years old and \<= 65 years old
• Patients who will receive chemoradiation with platinum/taxane based chemo and with a total radiation dose of \> or = 50 Gy, per treating physician's assessment
• Patients who speak English only (due to the novel research and its complexity, we are only accruing English speaking patients to the protocol)
• Patients must agree to discontinue any current herbal supplement use, and refrain from taking any herbal supplement while on protocol
• Patients must be willing and able to review, understand, and provide written consent before starting therapy
• Patients already taking any of this trial's symptom treatment medications (including modafinil) must be willing to stop taking the medication/s for a washout period of 30 days before they are randomized to a symptom treatment arm and begin the symptom trial

You may not qualify if:

• Patients who are taking medications or have conditions that potentially preclude use of any study medications or interventions as determined by the treating physician
• Patients taking CHANTIX (smoking cessation medication)
• Patients who are enrolled in other symptom management or treatment clinical trials
• Bile duct obstruction or cholelithiasis
• History of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reaction
• Pre-existing psychosis or bipolar disorder
• Pre-existing renal impairment: The screening cut off for serum creatinine \>1.5mg/dl will be done by the oncologist to qualify for CXRT.
• Pre-existing hepatic impairment: The screening for total bilirubin \>25.7 µmol/L (1.5 mg/dL) will be done by the oncologist to qualify for chemoradiation treatment (CXRT). The screening for 2 times the upper limit of normal Hepatotoxicity (Aspartate aminotransferase (AST), Alkaline phosphatase (ALP) and Alanine aminotransferase (ALT) will be done by the oncologist to qualify for CXRT.
• Pre-existing Tourette's syndrome
• Seizure disorder
• Anorexia/bulimia in past two months
• Use of monoamine oxidase (MAO) inhibitors within 14 days
• Patients undergoing abrupt discontinuation of ethanol or sedatives (including benzodiazepines)
• Patients receiving other dosage forms of bupropion if they do not agree to undergo a washout period
• Allergy to turmeric or any of its constituents, including curcumin, to yellow food coloring, or to member of the Zingiberaceae (ginger) family

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; cyclopia sequence

Interventions

Modafinil; Bupropion; Minocycline; Curcumin; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propiophenones; Ketones; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Catechols; Phenols; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Zhongxing Liao, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 14, 2010
• Last Updated: March 5, 2015

Record last verified: 2015-03