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

• Sponsor: Alliance for Clinical Trials in Oncology (Other)
• Overall Status: Completed
• CT.gov ID: NCT00005850
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 21
• Locations: 43
• Arm: 1
• Duration (Months): 25
• Patients Per Site: 0.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This trial is designed to test the efficacy of fluoxetine to improve patient's quality of life during chemotherapy. An innovative application of a selective serotonin reuptake inhibitor may modulate the effects of fatigue, anxiety and depression which worsen quality of life.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorder; Depression; Fatigue; Lung Cancer	Drug: cisplatin; Drug: fluoxetine; Drug: gemcitabine hydrochloride	Phase 2

Detailed Description

OBJECTIVES:

Primary Objectives:

1. To preliminarily test the efficacy of fluoxetine to improve the quality of life of patients with advanced non-small cell lung cancer receiving chemotherapy by decreasing anxiety, depression and fatigue.

2. To test the feasibility of conducting a multi-center clinical trial of fluoxetine administered by oncologists concurrently with chemotherapy in patients with non-small cell lung cancer.

Secondary Objectives:

1. To describe the tumor response rate associated with the administration of gemcitabine/cisplatin in patients with advanced non-small cell lung cancer.

2. To describe the overall survival and failure-free survival associated with the administration of gemcitabine/cisplatin.

3. To describe the toxicity associated with the administration of gemcitabine/cisplatin.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Fluoxetine in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC): A Phase II Pilot Study to Improve Quality of Life During Chemotherapy
• Study Start Date: Aug 1, 2001
• Actual Primary Completion Date: Sep 1, 2003
• Actual Study Completion Date: Sep 1, 2003

Arms and Interventions

Arm

Intervention/Treatment

Experimental: gemcitabine + cisplatin + fluoxetine Patients receive gemcitabine and cisplatin. Treatment repeats every 21 days for a total of six cycles. Patients receive fluoxetine for 7 weeks. Further use of fluoxetine is at the discretion of the patient and physician.

Drug: cisplatin; 80 mg/m2 administered by intravenous (IV) over 30 minutes on Day 1 following the gemcitabine infusion. Treatment repeated every 21 days for a total of 6 cycles.; Drug: fluoxetine; 10 mg PO QD (by mouth once daily) starting on week 2 (day 8) and continuing for 7 weeks (days 8-57). After 7 weeks of fluoxetine treatment (day 57), further use of fluoxetine is at the discretion of the patient and physician.; Drug: gemcitabine hydrochloride; 1000 mg/m2 intravenous (IV) administered by IV over 30 minutes on days 1 and 8. Repeat treatment every 21 days for a total of 6 cycles.

Outcome Measures

Primary Outcome Measures

1. Change in the MHI-17 global psychological distress subscale [Up to 8 weeks]

2. Overall survival [Up to 2 years post-treatment]

3. Failure-free survival [Up to 2 years post-treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Eligibility Criteria:

1. Histologic Documentation: All patients must have histologically or cytologically documented, non-small cell carcinoma of the lung (adenocarcinoma, large cell, squamous, or mixtures of these types).

2. Extent of Disease: Stage IIIB/IV cancer by the international staging system or any Stage I-IIIA otherwise eligible patient with recurrent or progressive NSCLC after surgery or radiotherapy.

• Patients with Stage IIIB because of a malignant pleural effusion, supraclavicular node involvement, or contralateral hilar nodes are eligible (IIIB patients eligible for CALGB protocols of combined chemotherapy and chest irradiation are not eligible.

• Patients with known CNS metastases are not eligible.

1. Measurable or Non-Measurable Disease

• Measurable Disease: Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan.

• Non-measurable Disease: Only those non-measurable disease patients with ill-defined masses associated with post-obstructive changes and diffuse parenchymal malignant disease are eligible. All other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions, are not eligible.

Lesions that are considered non-measurable include the following:

• Bone lesions

• Leptomeningeal disease

• Ascites

• Pleural/pericardial effusion

• Abdominal masses that are not confirmed and followed by imaging techniques

• Cystic lesions

1. Prior Treatment:

• No prior chemotherapy.

• ≥ 2 weeks since radiation therapy.

• No antidepressant treatment (eg, selective serotonin reuptake inhibitors, tricyclics, novel antidepressants, St. John's Wort or monoamine oxidase inhibitors) currently or within the last month.

1. If the patient requires pain medication, pain must be managed with non-codeine preparations, including but not limited to: acetaminophen, any morphine based preparation (short or long acting), hydromorphone, fentanyl, levorphanol or methadone.

2. CTC Performance Status 0-1.

3. Non-pregnant and non-nursing because of significant risk to the fetus/infant.

4. Required Initial Laboratory Data:

• Granulocytes ≥ 1,500/µl

• Platelet count ≥ 100,000/µl

• Serum creatinine ≤ 1.5 mg/dl or Calculated CrCl ≥ 60 ml/min

• Bilirubin ≤ 2.0 x Upper Limit of Normal (ULN)

• Serum glutamic oxaloacetic transaminase (SGOT) ≤ 2.0 x ULN

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northeast Alabama Regional Medical Center	Anniston	Alabama	United States	36207
2	Veterans Affairs Medical Center - San Diego	San Diego	California	United States	92161
3	Veterans Affairs Medical Center - Washington, DC	Washington	District of Columbia	United States	20422
4	Broward General Medical Center	Fort Lauderdale	Florida	United States	33316
5	Memorial Regional Hospital Comprehensive Cancer Center	Hollywood	Florida	United States	33021
6	Florida Hospital Cancer Institute	Orlando	Florida	United States	32804
7	Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center	West Palm Beach	Florida	United States	33401
8	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
9	Louis A. Weiss Memorial Hospital	Chicago	Illinois	United States	60640
10	West Suburban Center for Cancer Care	River Forest	Illinois	United States	60305
11	Saint Anthony Medical Center	Rockford	Illinois	United States	61108
12	Fort Wayne Medical Oncology and Hematology, Incorporated	Fort Wayne	Indiana	United States	46885-5099
13	Baptist Hospital East - Louisville	Louisville	Kentucky	United States	40207
14	Veterans Affairs Medical Center - Baltimore	Baltimore	Maryland	United States	21201
15	Massachusetts General Hospital Cancer Center	Boston	Massachusetts	United States	02114
16	Beth Israel Medical Center	Boston	Massachusetts	United States	02115
17	Lakeland Medical Center - St. Joseph	Saint Joseph	Michigan	United States	49085
18	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri	United States	65203
19	Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
20	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-7680
21	Veterans Affairs Medical Center - Las Vegas	Las Vegas	Nevada	United States	89106
22	Cooper University Hospital	Camden	New Jersey	United States	08103
23	Elmhurst Hospital Center	Elmhurst	New York	United States	11373
24	Queens Cancer Center of Queens Hospital	Jamaica	New York	United States	11432
25	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
26	State University of New York - Upstate Medical University	Syracuse	New York	United States	13210
27	Veterans Affairs Medical Center - Syracuse	Syracuse	New York	United States	13210
28	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York	United States	13217
29	Veterans Affairs Medical Center - Asheville	Asheville	North Carolina	United States	28805
30	NorthEast Oncology Associates	Concord	North Carolina	United States	28025
31	Veterans Affairs Medical Center - Durham	Durham	North Carolina	United States	27705
32	Cape Fear Valley Health System	Fayetteville	North Carolina	United States	28302-2000
33	Lenoir Memorial Hospital Cancer Center	Kinston	North Carolina	United States	28503-1678
34	FirstHealth Moore Regional Hospital	Pinehurst	North Carolina	United States	28374
35	New Hanover Regional Medical Center	Wilmington	North Carolina	United States	28402-9025
36	Veterans Affairs Medical Center - Fargo	Fargo	North Dakota	United States	58102
37	Veterans Affairs Medical Center - Dallas	Dallas	Texas	United States	75216
38	Martha Jefferson Hospital	Charlottesville	Virginia	United States	22901
39	Virginia Oncology Associates - Norfolk	Norfolk	Virginia	United States	23502
40	Oncology and Hematology Associates of Southwest Virginia, Inc.	Roanoke	Virginia	United States	24014
41	St. Mary's Medical Center	Huntington	West Virginia	United States	25701
42	Ministry Medical Group - Northern Region	Rhinelander	Wisconsin	United States	54501
43	University of Puerto Rico School of Medicine Medical Sciences Campus	San Juan		Puerto Rico	00936-5067

Sponsors and Collaborators

• Alliance for Clinical Trials in Oncology
• National Cancer Institute (NCI)

Investigators

• Study Chair: Donna Greenberg, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT00005850
• Other Study ID Numbers: CALGB-119802; U10CA031946; CLB-119802; CDR0000067871
• First Posted: Jan 27, 2003
• Last Update Posted: Jul 4, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by Alliance for Clinical Trials in Oncology: 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: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Fatigue; Depression; Anxiety Disorders; Gemcitabine; Fluoxetine

Study Results

No Results Posted as of Jul 4, 2016