Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00005850

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells. An antidepressant such as fluoxetine may improve the quality of life in patients undergoing chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus fluoxetine in treating patients who have advanced or recurrent non-small cell lung cancer.

Condition	Intervention	Phase
Anxiety Disorder Depression Fatigue Lung Cancer	Drug: cisplatin Drug: fluoxetine Drug: gemcitabine hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Fluoxetine in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC): Phase II Pilot Study to Improve Quality of Life During Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Cancer Depression Fatigue Lung Cancer

Drug Information available for: Cisplatin Fluoxetine Fluoxetine hydrochloride Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:

QOL [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Enrollment:	21
Study Start Date:	August 2001
Primary Completion Date:	September 2003 (Final data collection date for primary outcome measure)

Intervention Details:

80 mg/sq m IV Day 1 each cycle

10 mg PO per day starting day 8

1000 mg/sq m IV on days 1 and 8 of each cycle

Detailed Description:

OBJECTIVES:

Determine the efficacy of fluoxetine in improving the quality of life by decreasing anxiety, depression, and fatigue in patients with advanced or recurrent non-small cell lung cancer when treated with gemcitabine and cisplatin.
Determine the response rate, failure-free survival, and overall survival of patients treated with gemcitabine and cisplatin.
Assess the toxicity of gemcitabine and cisplatin in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 30 minutes (beginning after gemcitabine infusion) on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral fluoxetine once daily on days 8-57. Patients may continue receiving fluoxetine after day 57 at the discretion of the patient and physician.

Quality of life is assessed at baseline and then after receiving fluoxetine for 7 weeks (days 57-61).

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within approximately 9 months.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell carcinoma of the lung (adenocarcinoma, large cell, squamous, or any mixture of these types)
- One of the following stages:
  - Stage IIIB
    - Malignant pleural effusion
    - Supraclavicular node involvement
    - Contralateral hilar nodes
  - Stage IV
  - Stage I-IIIA with recurrent or progressive disease after prior surgery or radiotherapy
At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques OR
- At least 10 mm by spiral CT scan
Non-measurable disease only allowed if there are concurrent ill-defined masses associated with post-obstructive changes and diffuse parenchymal malignant disease
Lesions that are considered non-measurable:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Abdominal masses not confirmed or followed by imaging
- Cystic lesions
No known CNS metastases

PATIENT CHARACTERISTICS:

Age:

Not specified

Performance status:

CTC 0-1

Life expectancy:

Not specified

Hematopoietic:

Granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3

Hepatic:

Bilirubin no greater than 2 times upper limit of normal (ULN)
SGOT no greater than 2 times ULN

Renal:

Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min

Other:

Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy
No other concurrent chemotherapy

Endocrine therapy:

No concurrent steroids except for adrenal failure
No concurrent hormonal therapy except for nondisease-related conditions (e.g., insulin for diabetes)
Concurrent dexamethasone allowed as antiemetic if used intermittently

Radiotherapy:

See Disease Characteristics
At least 2 weeks since prior radiotherapy
No concurrent radiotherapy, including for palliation

Surgery:

See Disease Characteristics

Other:

At least 1 month since prior antidepressant treatment (e.g., selective serotonin reuptake inhibitors, tricyclics, novel antidepressants, St. John's Wort, or monoamine oxidase inhibitors)
No other concurrent antidepressant treatment, including St. John's Wort
No concurrent codeine preparations for pain

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005850

Show 43 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Donna Greenberg, MD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Monica M Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00005850 History of Changes
Other Study ID Numbers:	CDR0000067871, U10CA031946, CLB-119802
Study First Received:	June 2, 2000
Last Updated:	June 21, 2011
Health Authority:	United States: Federal Government

Keywords provided by Cancer and Leukemia Group B:

stage I non-small cell lung cancer
stage II non-small cell lung cancer
recurrent non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

stage IV non-small cell lung cancer
adenocarcinoma of the lung
adenosquamous cell lung cancer
fatigue
anxiety disorder
depression

Additional relevant MeSH terms:

Anxiety Disorders
Carcinoma, Non-Small-Cell Lung
Depression
Depressive Disorder
Fatigue
Lung Neoplasms
Mental Disorders
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

Behavioral Symptoms
Mood Disorders
Signs and Symptoms
Gemcitabine
Cisplatin
Fluoxetine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012