Pemetrexed Disodium and Cisplatin in Treating Patients Who Are Undergoing Surgery for Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Molecular and Genetic Changes in Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) Following Neoadjuvant Chemotherapy With Cisplatin and Alimta - Phase II Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00248495
• Other study ID #: CDR0000441025
• Secondary ID: RPCI I-31104
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 3, 2005
• Last updated: September 9, 2016
• Start date: June 2005

Study information

• Verified date: September 2016
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: 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 more than one drug (combination chemotherapy) and giving them before and after surgery may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and cisplatin before and after surgery works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.

Description:

OBJECTIVES:

Primary

• Determine the pathologic complete response in patients with stage IB-IIIB non-small cell lung cancer treated with neoadjuvant chemotherapy comprising pemetrexed disodium and cisplatin followed by surgery and adjuvant pemetrexed disodium and cisplatin.

Secondary

• Determine the adverse events of this regimen in these patients.

• Determine the overall and disease-free survival of patients treated with this regimen.

• Correlate response with the presence or absence of ERCC1 and DHFR, thymidylate synthase, DPD, and GARFT in patients treated with this regimen.

• Correlate the fragile site on chromosome 12 within the SMRT gene with metastasis after definitive treatment with this regimen in these patients.

OUTLINE:

• Neoadjuvant chemotherapy: Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses. Patients are then evaluated for disease resectability. Patients with no evidence of disease progression proceed to thoracotomy within the next 28-48 days.

• Thoracotomy: Patients found to have unresectable disease during thoracotomy receive further treatment off study. Patients with resectable disease undergo complete surgical resection of the tumor. Forty to eighty days later, patients proceed to adjuvant chemotherapy.

• Adjuvant chemotherapy: Patients receive pemetrexed disodium and cisplatin as before for 2 courses.

Patients with progressive disease after completion of neoadjuvant chemotherapy are followed every 6 months. All other patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study over 6.5 years.

Other known NCT identifiers

• NCT01731626

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Microscopically confirmed non-small cell lung cancer

• Stage IB (T2, N0, M0), IIA (T1, N1, M0), IIB (T2, N1, M0 or T3, N0, M0), or IIIA (T1-3, N1-2, M0) disease

• Satellite lesions in one lobe (T4) (stage IIIB) allowed

• Meets 1 of the following criteria:

• Measurable disease, defined as = 1 unidimensionally measurable lesion = 10 mm in the longest diameter

• Evaluable disease, defined as lesions on chest CT scan that are not measurable (e.g., ill-defined masses or mediastinal or hilar adenopathy)

• No metastatic disease except peribronchial/hilar lymph nodes (N1) or ipsilateral/subcarinal mediastinal lymph nodes (N2)

• No N3 lymph nodes (e.g., contralateral mediastinal/hilar or supraclavicular/scalene) by CT scan or positron emission tomography (PET) scan AND mediastinoscopy

• No T4 primary tumor (e.g., mediastinal invasion)

• No malignant pleural effusion

• Nonmalignant effusions (i.e., negative cytology, non-bloody, and transudate) allowed

• Effusions visible only by CT scan and not large enough for safe thoracentesis allowed

• No exudative effusion, defined by 1 of the following criteria:

• Pleural fluid protein:serum protein ratio > 0.5

• Pleural fluid lactic dehydrogenase (LDH):serum LDH ratio = 0.6

• Pleural fluid LDH > 200 IU/L

• No more than 1 area of fludeoxyglucose (FDG) uptake outside the area of the primary lung tumor OR evidence of malignant pleural disease as evidenced by pleural nodules by PET scan

• Single areas of FDG uptake will be further evaluated (e.g., by biopsy) for metastatic disease

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC = 3,000/mm^3

• Platelet count = 100,000/mm^3

• Hemoglobin = 9 g/dL

Hepatic

• Bilirubin = 1.5 mg/dL

• SGOT or SGPT = 1.5 times upper limit of normal

Renal

• Creatinine clearance = 45 mL/min

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after completion of study treatment

• No other active malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

• No psychological, familial, sociological, or geographical situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for lung cancer

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy for lung cancer

Surgery

• No prior surgery for lung cancer

• At least 12 weeks since prior major surgery to the chest and abdomen

Other

• No concurrent aspirin or other nonsteroidal anti-inflammatory drugs for = 2 days before (5 days for drugs with a long half-life [e.g., naproxen, piraoxicam, difunisal, nabumetone, rofecoxib, or celecoxib] or 8 days for long acting agents), during, and for 2 days after completion of each pemetrexed disodium administration

• No concurrent participation in another study involving chemotherapy or radiotherapy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• cisplatin
Given IV
• pemetrexed disodium
Given IV

Procedure:
• adjuvant therapy
Metastasis prevention/control
• conventional surgery
Undergoing tissue removal
• neoadjuvant therapy
Tumor Reduction

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologically complete response		1 year	No