Preoperative Pemetrexed and Carboplatin for Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2009
End Date:August 2015

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Phase II Trial of Preoperative Pemetrexed and Carboplatin in Patients With Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer

The purpose of this multi-center Phase II trial is to examine the impact of
pemetrexed/carboplatin in the preoperative treatment of patients with select stage IB,
II,and III non-squamous NSCLC. Because patients with non-squamous type NSCLC have been shown
to have better survival rates than patients with squamous tumors when given pemetrexed with
a platinum agent, only patients with non-squamous NSCLC (adenocarcinoma, large cell, and
undifferentiated), not including squamous histology, will be allowed to participate in this
study. If this novel regimen proves to be safe and active in this setting, it will provide
rationale for further investigation in a larger, prospective, randomized trial.


Inclusion Criteria:

1. Histologically-confirmed NSCLC (adenocarcinoma, large cell, and undifferentiated).
Patients with squamous histology are not eligible.

2. Life expectancy of at least 12 weeks.

3. Patients with the following stages of NSCLC:

- T2 N0 tumors: Limited to tumors >=4 cm.

- T1-2 N1 tumors.

- T3 N0-1 tumors (excluding superior sulcus tumors): Including tumors involving
the chest wall, proximal airway, or mediastinal pleura where preoperative
radiotherapy is not planned.

- T1-2 N2 tumors: For patients with N2 disease involving one zone (Upper zone (R),
AP zone (L), subcarinal zone, or lower zone) and nodes <=2cm in diameter.

- T4 N0-1 tumors (excluding superior sulcus tumors): T4 lesions other than
malignant effusions where radiotherapy is not planned.

4. Patients with clinical N2 involvement must have histologic confirmation by
mediastinoscopy (or alternate biopsy procedure).

5. Tumors should be considered potentially resectable.

6. No evidence of extrathoracic metastatic disease.

7. Patients must have measurable disease by RECIST criteria.

8. Patients must be candidates (medically) for chemotherapy followed by surgical
resection.

9. Adequate recovery from recent surgery. At least 1 week must have elapsed from the
time of a minor surgery; at least 3 weeks must have elapsed from the time of a major
surgery.

10. Laboratory values as follows:

- Absolute neutrophil count (ANC) >=1500/μL

- Hemoglobin (Hgb) >=10 g/dL

- Platelets >=100,000/uL

- AST/SGOT and ALT/SGPT within normal limits (WNL)

- Total bilirubin within normal limits (WNL)

- Calculated creatinine clearance >=45 mL/min

11. ECOG Performance Status grade 0 or 1.

12. The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the
day of, and 2 days following administration of Alimta.

13. The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.

14. Women of childbearing potential must have a negative serum or urine pregnancy test
performed within 7 days prior to start of treatment. Women of childbearing potential
or men with partners of childbearing potential must use effective birth control
measures during treatment. If a woman becomes pregnant or suspects she is pregnant
while participating in this study, she must agree to inform her treating physician
immediately.

15. Patient must be accessible for treatment and follow-up.

16. Patients must be able to understand the investigational nature of this study and give
written informed consent prior to study entry.

Exclusion Criteria:

1. Patients with the following stages are excluded:

- T1 N0;

- T2 N0, with primary tumor <4 cm;

- T1-2 N2, with multiple zones of N2 involvement;

- T3-4 N2;

- Any N3;

- Any TxNxM1 disease; or

- Any stage where surgery and/or chemoradiotherapy is the preferred initial
approach in management, as deemed by the treating physician.

2. Squamous or predominant squamous mixed histologies.

3. Mixed small-cell and non-small cell histologies.

4. Pulmonary carcinoid tumors.

5. Presence of third space fluid which cannot be controlled by drainage.

6. Use of erythropoietin as a hematopoietic growth factor is not allowed.

7. Cardiac disease, including: congestive heart failure (CHF) > Class II per New York
Heart Association (NYHA) classification; unstable angina (anginal symptoms at rest)
or new-onset angina (i.e., began within the last 3 months), or myocardial infarction
within the past 6 months; symptomatic CHF, unstable angina pectoris, cardiac
arrhythmia, or cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.

8. Women who are pregnant (positive pregnancy test) or lactating.

9. Use of any non-approved or investigational agent within 30 days of administration of
the first dose of study drug.

10. Patients may not receive any other investigational or anti-cancer treatments while
participating in this study.

11. Concurrent severe, intercurrent illness including, but not limited to, ongoing or
active infection, or psychiatric illness/social situations that would limit
compliance with study requirements.

12. Mental condition that would prevent patient comprehension of the nature of, and risk
associated with, the study.

13. History of hypersensitivity to active or inactive excipients of any component of
treatment.

14. Inability to comply with study and/or follow-up procedures.
We found this trial at
12
sites
6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Bethesda, MD
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166 Stoneridge Drive
Columbia, South Carolina 29210
803-461-3000
South Carolina Oncology Associates, PA South Carolina Oncology Associates (SCOA) is the only comprehensive cancer...
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Columbia, SC
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3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
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Fort Myers, FL
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Augusta, GA
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Bethesda, MD
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Chattanooga, Tennessee 37404
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Chattanooga, TN
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Cincinnati, OH
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743 Spring St NE
Gainesville, Georgia 30501
770-219-9000
Northeast Georgia Medical Center Northeast Georgia Health System (NGHS) is a not-for-profit community health system...
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Gainesville, GA
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Louisville, Kentucky 40207
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Louisville, KY
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Nashville, TN
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Omaha, Nebraska 68114
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Omaha, NE
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Richmond, Virginia 23235
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Richmond, VA
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