Positron Emission Tomography in Predicting Response in Patients Who Are Undergoing Treatment With Pemetrexed Disodium and Cisplatin With or Without Surgery for Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
This study has been completed.
Sponsor:
University of Washington
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00227539
First received: September 26, 2005
Last updated: January 6, 2014
Last verified: January 2014
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Purpose
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET), (done before, during, and after chemotherapy) may help doctors predict a patient's response to treatment and help plan the best treatment. Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well PET works in predicting response in patients who are undergoing treatment with pemetrexed disodium and cisplatin with or without surgery for stage I, stage II, or stage III non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: cisplatin Drug: pemetrexed disodium Procedure: adjuvant therapy Procedure: therapeutic conventional surgery Radiation: fludeoxyglucose F 18 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Early Positron Emission Tomography as a Predictor of Response in Neoadjuvant Chemotherapy for Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by University of Washington:
Primary Outcome Measures:
- Positron emission tomography as a predictor of response measured by the decrease in standard uptake variable (SUV) after 1 course of therapy [ Time Frame: Between days 18 and 22 prior to second chemotherapy infusion ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety of neoadjuvant chemotherapy [ Time Frame: Up to 4 weeks after last dose of chemotherapy ] [ Designated as safety issue: Yes ]
- Efficacy of neoadjuvant chemotherapy as measured by radiologic response rate [ Time Frame: Up to 4 weeks after last dose of chemotherapy ] [ Designated as safety issue: No ]
| Enrollment: | 25 |
| Study Start Date: | July 2005 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Neoadjuvant therapy, PET scan and surgery | Drug: cisplatin Drug: pemetrexed disodium Procedure: adjuvant therapy Procedure: therapeutic conventional surgery Radiation: fludeoxyglucose F 18 |
Detailed Description:
OBJECTIVES:
Primary
- Determine the effectiveness of fludeoxyglucose F 18 positron emission tomography in predicting radiological and pathological response in patients treated with pemetrexed disodium and cisplatin with or without surgery for stage IB-IIIB non-small cell lung cancer (NSCLC).
Secondary
- Determine the safety of cisplatin and pemetrexed disodium in these patients.
- Determine the radiographic response rate, duration of response, and time to progression in patients treated with cisplatin and pemetrexed disodium.
OUTLINE: This is a multicenter study.
- Fludeoxyglucose F 18 (18FDG) positron emission tomography (PET) imaging: All patients undergo positron emission tomography (PET) imaging of the head, neck, thorax, abdomen, and pelvis. Patients receive fludeoxyglucose F 18 (^18FDG) IV followed by 45 minutes of rest. PET imaging is done over 1 hour and 8 minutes. Patients undergo PET imaging at three points during the study: 4 weeks prior to treatment, after the first cycle of treatment, and after 3 courses of chemotherapy. Some patients then undergo surgical resection of the tumor.
- Chemotherapy: Patients receive cisplatin IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
-
Stage IB, II, IIIA, or IIIB (T4, N0-1) disease
- Staging must have been performed 4 weeks prior to study entry with a CT scan of chest, upper abdomen, and fludeoxyglucose F 18 (^18FDG) positron emission tomography (PET) scan
- Mediastinal evaluation and staging based on combination of CT scan and FDG-PET results
- If N1 or N2 nodes are found by FDG-PET or CT scan, metastases must be ruled out by brain MRI
-
Measurable and resectable disease
- T4 lesions must be resectable
- Eligible for curative surgery
- No malignant pleural effusion
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,250/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 3.0 times ULN
Renal
- Creatinine clearance ≥ 45 mL/min
Pulmonary
-
Adequate pulmonary reserve to undergo surgery
- Predicted FEV_1 > 0.8 L after resection
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- Able to take corticosteroids
- Able to take folic acid or vitamin B_12 supplements
- No other malignancy within the past 5 years except nonmelanoma skin cancer or noninvasive cervical cancer
- No concurrent serious or uncontrolled disorder that would preclude study participation
-
No type I diabetes mellitus
- Type II diabetes mellitus allowed if glucose is 80-150 mg/dL
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
- No concurrent prophylactic filgrastim (G-CSF)
- No concurrent thrombopoiesis-stimulating agents
Chemotherapy
- At least 5 years since prior chemotherapy
Endocrine therapy
- No concurrent anticancer hormonal therapy
Radiotherapy
- No prior radiotherapy to the chest
- No concurrent curative or palliative radiotherapy
Surgery
- Not specified
Other
- At least 30 days since prior non-FDA-approved or investigational agents
- At least 5 days since prior aspirin or other nonsteroidal anti-inflammatory agents (8 days for long-acting agents [e.g., piroxicam])
- No other concurrent anticancer therapy
- No other concurrent investigational agents
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227539
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227539
Locations
| United States, Washington | |
| Seattle Cancer Care Alliance | |
| Seattle, Washington, United States, 98109-1023 | |
| University of Washington School of Medicine | |
| Seattle, Washington, United States, 98195 | |
Sponsors and Collaborators
University of Washington
Investigators
| Principal Investigator: | Renato Martins, MD, MPH | Seattle Cancer Care Alliance |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Washington |
| ClinicalTrials.gov Identifier: | NCT00227539 History of Changes |
| Other Study ID Numbers: | 6228, P30CA015704, UWCC-6228, UWCC-UW-6228, UW-04033, LILY-UW-04033, CDR0000441239 |
| Study First Received: | September 26, 2005 |
| Last Updated: | January 6, 2014 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by University of Washington:
|
stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms |
Pemetrexed Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015