Preoperative Pemetrexed and Carboplatin for Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT00906282 |
Recruitment Status :
Completed
First Posted : May 21, 2009
Results First Posted : February 24, 2017
Last Update Posted : February 24, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Small Cell Lung Cancer | Drug: Pemetrexed Drug: Carboplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 46 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial of Preoperative Pemetrexed and Carboplatin in Patients With Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | August 2015 |
Actual Study Completion Date : | September 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Pemetrexed/Carboplatin
4 cycles of preoperative treatment (1 Cycle = 21 days): Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle; Carboplatin: AUC 6.0 by IV on Day 1 each cycle. |
Drug: Pemetrexed
500 mg/m2 IV over 10 minutes on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).
Other Name: Alimta Drug: Carboplatin AUC 6.0 IV on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).
Other Name: 41575-94-4 |
- 3-Year Overall Survival Rate [ Time Frame: 36 months ]The percentage of patients who were alive at 3 years from time of first study treatment until date of death from any cause. Overall survival is shown for the Intent-to-Treat population.
- Objective Tumor Response [ Time Frame: At 6 and 12 weeks ]Objective Tumor Response defined as the percent of patients who completed up to 4 cycles of pre-operative chemotherapy and achieved a complete response (CR) or partial response (PR) assessed by Response Evaluation in Solid Tumors (RECIST) 1.0. Patients with stable disease (SD) or response to treatment were deemed surgical candidates. [CR=disappearance of all target tumors; PR= ≥30% decrease in the sum of the longest diameters of target tumors. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.]
- Pathologic Response Rate [ Time Frame: weeks 15 -18 ]Percent of patients having a pathological complete or partial response (pCR or pPR) at surgery. pCR defined as complete removal of all tumor. pPR defined as residual viable tumor demonstrated in the resected specimen.
- Rate of Residual Disease as an Assessment of Pathological Partial Response (pPR) [ Time Frame: At 15-18 weeks ]pPR was further assessed by the amount of residual tumor measured at surgery: microscopic residual disease = less than 1 centimeter (<1 cm); macroscopic residual disease = 1 centimeter or greater (≥1 cm).
- Complete Resection Rate [ Time Frame: At weeks 15-18 ]The percent of patients who had surgical resection listed by procedure type: lobectomy or pneumonectomy, or resection of adjacent chest wall or mediastinal structures when appropriate. Surgery followed standard guidelines for resection of non-small-cell lung cancer (NSCLC).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically-confirmed NSCLC (adenocarcinoma, large cell, and undifferentiated). Patients with squamous histology are not eligible.
- Life expectancy of at least 12 weeks.
-
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.
- Patients with clinical N2 involvement must have histologic confirmation by mediastinoscopy (or alternate biopsy procedure).
- Tumors should be considered potentially resectable.
- No evidence of extrathoracic metastatic disease.
- Patients must have measurable disease by RECIST criteria.
- Patients must be candidates (medically) for chemotherapy followed by surgical resection.
- 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.
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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
- ECOG Performance Status grade 0 or 1.
- The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Alimta.
- The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.
- 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.
- Patient must be accessible for treatment and follow-up.
- Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.
Exclusion Criteria:
-
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.
- Squamous or predominant squamous mixed histologies.
- Mixed small-cell and non-small cell histologies.
- Pulmonary carcinoid tumors.
- Presence of third space fluid which cannot be controlled by drainage.
- Use of erythropoietin as a hematopoietic growth factor is not allowed.
- 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.
- Women who are pregnant (positive pregnancy test) or lactating.
- Use of any non-approved or investigational agent within 30 days of administration of the first dose of study drug.
- Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
- 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.
- Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
- History of hypersensitivity to active or inactive excipients of any component of treatment.
- Inability to comply with study and/or follow-up procedures.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00906282
United States, Florida | |
Florida Cancer Specialists | |
Fort Myers, Florida, United States, 33901 | |
United States, Georgia | |
Medical Oncology Associates of Augusta | |
Augusta, Georgia, United States, 30901 | |
Northeast Georgia Medical Center | |
Gainesville, Georgia, United States, 30501 | |
United States, Kentucky | |
Baptist Hospital East | |
Louisville, Kentucky, United States, 40207 | |
United States, Maryland | |
Center for Cancer and Blood Disorders | |
Bethesda, Maryland, United States, 20817 | |
National Capital Clinical Research Consortium | |
Bethesda, Maryland, United States, 20817 | |
United States, Nebraska | |
Nebraska Methodist Cancer Center | |
Omaha, Nebraska, United States, 68114 | |
United States, Ohio | |
Oncology Hematology Care | |
Cincinnati, Ohio, United States, 45242 | |
United States, South Carolina | |
South Carolina Oncology Associates, PA | |
Columbia, South Carolina, United States, 29210 | |
United States, Tennessee | |
Chattanooga Oncology Hematology Associates | |
Chattanooga, Tennessee, United States, 37404 | |
Tennessee Oncology, PLLC | |
Nashville, Tennessee, United States, 37023 | |
United States, Virginia | |
Virginia Cancer Institute | |
Richmond, Virginia, United States, 23235 |
Study Chair: | David R Spigel, M.D. | SCRI Development Innovations, LLC |
Responsible Party: | SCRI Development Innovations, LLC |
ClinicalTrials.gov Identifier: | NCT00906282 |
Other Study ID Numbers: |
SCRI LUN 186 |
First Posted: | May 21, 2009 Key Record Dates |
Results First Posted: | February 24, 2017 |
Last Update Posted: | February 24, 2017 |
Last Verified: | January 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
neoadjuvant NSCLC NSCLC pemetrexed |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic |
Bronchial Neoplasms Carboplatin Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |