Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Alliance for Clinical Trials in Oncology
With
National Cancer Institute (NCI)
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.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
3. 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.
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
4. 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.
5. 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.
6. CTC Performance Status 0-1.
7. Non-pregnant and non-nursing because of significant risk to the fetus/infant.
