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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

Phase 2
18 Years
Open (Enrolling)
Non Small Cell Lung Cancer

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Trial Information

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

Inclusion Criteria:

1. Age >=18 years.

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

3. Life expectancy of at least 12 weeks.

4. 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.

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

6. Tumors should be considered potentially resectable.

7. No evidence of extrathoracic metastatic disease.

8. Patients must have measurable disease by RECIST criteria.

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

10. 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

11. 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

12. ECOG Performance Status grade 0 or 1.

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

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

15. 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

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

17. 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

14. Inability to comply with study and/or follow-up procedures.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the overall survival rate at 3 years.

Outcome Time Frame:

54 months

Safety Issue:


Principal Investigator

David R Spigel, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

June 2009

Completion Date:

December 2014

Related Keywords:

  • Non Small Cell Lung Cancer
  • neoadjuvant NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Florida Cancer SpecialistsFort Myers, Florida  33901
Northeast Georgia Medical CenterGainesville, Georgia  30501
South Carolina Oncology Associates, PAColumbia, South Carolina  29210
Virginia Cancer InstituteRichmond, Virginia  23230
Medical Oncology Associates of AugustaAugusta, Georgia  30901
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Portsmouth Regional HospitalPortsmouth, New Hampshire  03802
Tennessee Oncology, PLLCClarksville, Tennessee  37043
Oncology Hematology CareCincinnati, Ohio  45242
Baptist Hospital EastLouisville, Kentucky  40207
National Capital Clinical Research ConsortiumBethesda, Maryland  20817
Chattanooga Oncology Hematology AssociatesChattanooga, Tennessee  37404
Nebraska Methodist Cancer CenterOmaha, Nebraska  68114