Pharmacogenomic & Phase II Study of Gemcitabine and Pemetrexed in Non-Small-Cell Lung Cancer.

NCT00226577 | Completed Phase 2 Results DMC

• 2 other identifiers: MCC-13726H3E-US-X009
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy and safety of chemotherapy given prior to having lung cancer surgically removed. Patients with resectable non-small cell lung cancer will receive gemcitabine and pemetrexed together for 4 times biweekly. Patients will be seen by a medical oncologist prior to each cycle of chemotherapy given. The medical oncologist will review patient's bloodwork and symptoms prior to approving next cycle of chemotherapy. All patients will then be evaluated with scans to determine response to chemotherapy and to determine if patient is a surgical candidate. These patients will then proceed to surgery to have the lung cancer removed. Follow up visits include bloodwork, scans, and a visit with the medical oncologist every three months for two years, then every six months for three years to monitor for disease recurrence.

Conditions

Lung Cancer

Keywords

Non-Small-Cell Lung Cancer; resectable; NSCLC

Outcome Measures

Primary Outcomes (1)

• Disease Response - Radiographic

  Number of participants with partial or Complete Response. Complete response (CR) is defined as the total disappearance of all malignant and evaluable clinical evidence of cancer without the development of any new malignant lesions documented on the post chemotherapy chest CT and PET scan. Partial response (PR) (measurable disease only): When compared with pre-treatment measurements, a reduction of \>30% in the sum of the largest diameters of all measurable lesions and absence of new lesions.

  06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006

Secondary Outcomes (4)

• Disease Response - Pathologic

  06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006

• Survival - Disease Free

  06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006

• Survival - Overall

  06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006

• Toxicity

  06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006

Study Arms (1)

Pre-Surgery Chemotherapy

EXPERIMENTAL

Drug: Gemcitabine; Drug: Pemetrexed; Procedure: Surgery

Interventions

Gemcitabine DRUG

Gemcitabine (GemzarR) 1500 mg/m2

Also known as: Gemzar®

Pre-Surgery Chemotherapy

Pemetrexed DRUG

Pemetrexed (AlimtaR) 500 mg/m2

Also known as: Alimta®

Pre-Surgery Chemotherapy

Surgery PROCEDURE

When the chemotherapy treatment is completed, the patient's tumor response will be evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). If there is no growth or spread of the cancer on any of these tests, patients will then proceed to have surgery by week 10 to remove the cancer.

Pre-Surgery Chemotherapy

Eligibility Criteria

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

You may qualify if:

• Microscopically confirmed non-small cell carcinoma of the lung, which may be confirmed at the initial bronchoscopy and mediastinoscopy, or by transthoracic needle biopsy.
• No prior therapy for lung cancer.
• Patients must have disease stages IB (T2N0M0), IIA (T1N1M0), IIB (T2N1M0 and T3N0M0), or IIIA (T3N1M0 and T1-3N2M0). Patients with 2 lesions in one lobe (T4) (Stage IIIB) are eligible.
• Patients must be deemed medically fit for surgical resection by a thoracic surgeon.
• Patients must have an ECOG performance status of Zero or One.
• Patients must have measurable or evaluable disease.
• Measurable Disease: Any mass reproducibly measurable in one diameter (RECIST criteria).
• Evaluable disease: Lesions apparent on chest CT, which do not meet the criteria for measurability. These include ill-defined masses associated with post obstructive changes.
• Age \>18 years.
• Patient must be able to understand and sign the informed consent.
• Patients must be \>12 weeks from prior major surgery, such as a coronary artery bypass graft.

You may not qualify if:

• White blood cell count \<3000/mm3
• Platelet count \<100,000/mm3
• Hemoglobin \<9.0 g/dl
• Creatinine \>1.5 mg/dl
• Total bilirubin \>1.5 mg/dl
• SGOT, SGPT, or AP \>1.5 x upper limit of normal
• Metastatic disease (except peribronchial/hilar lymph nodes=N1 and ipsilateral/subcarinal mediastinal lymph nodes=N2) or malignant pleural effusion detected on preoperative evaluation. Non-malignant effusions are cytology negative, are non-bloody, and are transudates. Effusions visible only on CT and not large enough for safe thoracentesis will not result in ineligibility. Exudative effusions, even if cytologically negative are excluded. Pleural fluid is considered exudative if: the ratio of pleural fluid protein to serum protein is \>0.5 or the ratio of pleural fluid LDH to serum to serum LDH \>0.6 or Pleural fluid LDH is \>200 IU/liter. A staging PET scan will be used to exclude patients. If there are multiple areas of FDG uptake outside the area of the primary tumor and the hilar and ipsilateral mediastinal lymph nodes, the patient will be excluded by virtue of having metastatic disease. If however, only one area shows an increase in FDG uptake, the area of concern will need further evaluation such as a biopsy to exclude metastatic disease.
• N3 lymph nodes (contralateral mediastinal/hilar and supraclavicular/scalene) or T4 primary tumor (malignant pleural effusion or mediastinal invasion) by clinical staging criteria (N3 as seen on CT or PET scan, which may be proven by mediastinoscopy at the investigators discretion).
• Pregnancy.
• Other active malignancy within 2 years with the exceptions of non-melanoma skin cancer and cervical carcinoma in situ.
• Psychologic, familial, sociologic, or geographic conditions, which do not permit biweekly medical follow-up and adherence to the study protocol.
• Prior radiation therapy for any cancer to the thorax.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Cancer Institute (NCI): collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

• Journal of Thoracic Oncology: Clinical Efficacy and Predictive Molecular Markers of Neoadjuvant Gemcitabine and Pemetrexed in Resectable Non-small Cell Lung Cancer

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine; Pemetrexed; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Gerold Bepler, M.D., Ph.D. via Moffitt Cancer Center
• Organization: Karmanos Cancer Institute

beplerg@karmanos.org

813-745-4398

Study Officials

• Gerold Bepler, M.D, Ph.D.

  H. Lee Moffitt Cancer Center (now at Karmanos Cancer Institute)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: September 23, 2005
• First Posted: September 27, 2005
• Study Start: February 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 23, 2017
• Results First Posted: January 12, 2011

Record last verified: 2011-01

Locations

US (1)