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

NCT00248495 | Completed Phase 2 Results DMC

• 2 other identifiers: CDR0000441025RPCI I-31104
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage II non-small cell lung cancer; stage I non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Pathologically Complete Response

  Pathologic Complete Response is defined by a surgical pathology specimen, which is free of all gross and microscopic evidence of viable tumor.

  1 year

Secondary Outcomes (5)

• Number of Participants With Adverse Events

  1 year

• Overall Survival

  Every 6 months until the time of death up to 126 months

• Disease Free Survival

  At least every 3 months after the completion of adjuvant therapy for two years and thereafter every 6 months for 3 years and then yearly up to 126 months

• Correlation Between Response and Markers Such as Presence or Absence of ERCC1 and DHFR, TS, DPD and GARFT

  1 year

• Percent Change in SUV Level Between Pre and Post Chemotherapy

  Baseline and post-chemotherapy

Study Arms (1)

Neoadjuvant chemotherapy

EXPERIMENTAL

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

Drug: cisplatin; Drug: pemetrexed disodium; Procedure: adjuvant therapy; Procedure: conventional surgery; Procedure: neoadjuvant therapy

Interventions

cisplatin DRUG

Given IV

Neoadjuvant chemotherapy

pemetrexed disodium DRUG

Given IV

Neoadjuvant chemotherapy

adjuvant therapy PROCEDURE

Metastasis prevention/control

Neoadjuvant chemotherapy

conventional surgery PROCEDURE

Undergoing tissue removal

Neoadjuvant chemotherapy

neoadjuvant therapy PROCEDURE

Tumor Reduction

Neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Pemetrexed; Chemotherapy, Adjuvant; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Combined Modality Therapy; Therapeutics; Drug Therapy

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Grace K. Dy, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2005
• First Posted: November 4, 2005
• Study Start: June 8, 2005
• Primary Completion: April 29, 2011
• Study Completion: April 5, 2017
• Last Updated: July 12, 2017
• Results First Posted: May 19, 2017

Record last verified: 2017-06

Locations

US (1)