Pemetrexed in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer

• ClinicalTrials.gov Identifier: NCT00216216
• Recruitment Status: Terminated
• First Posted: September 22, 2005
• Last Update Posted: May 2, 2011
• Sponsor: Hoosier Cancer Research Network
• Collaborators: Eli Lilly and Company; Walther Cancer Institute
• Information provided by: Hoosier Cancer Research Network

Study Description

Brief Summary:

Patients with relapsed or chemotherapy-refractory SCLC have a dismal prognosis. Unfortunately, available treatments result in few durable responses. Pemetrexed is a well-tolerated agent, which is active in NSCLC. Since chemotherapy agents, which are active in NSCLC, are usually also active in SCLC, this trial will examine the efficacy and activity of pemetrexed in this palliative setting

Condition or disease	Intervention/treatment	Phase
Small Cell Lung Cancer	Drug: Pemetrexed	Phase 2

Detailed Description:

OUTLINE: This is a multi-center study.

• Pemetrexed 500 mg/m2 i.v. q 3 wks

All patients will also receive folic acid 350-1000 mcg. po once daily beginning approximately 1 week prior to the first dose of pemetrexed and continuing until completion of pemetrexed, Vitamin B12 1000 mcg. IM every 9 weeks beginning approximately 1 week prior to the first dose of pemetrexed and continuing until completion of pemetrexed, and dexamethasone 4 mg po bid the day before, the day of, and the day following each treatment with pemetrexed

Chest x-ray will be performed prior to each cycle (if other disease assessment by imaging is not performed) in order to ensure patients are not rapidly progressing.

Cycles are repeated every 3 weeks for up to 6 cycles or PD or intolerable side effects.

Performance Status: ECOG 0, 1, or 2

Life Expectancy: Not specified

Hematopoietic:

• WBC > 3000/mm3
• ANC > 1500/mm3
• Platelet count > 100,000/mm3
• Hemoglobin > 8 g/dL

Hepatic:

• Bilirubin < 1.0 X upper limit of normal
• Aspartate aminotransferase (AST, SGOT) < 2.5 x upper limit of normal. AST may be < 5 x upper limit of normal for patients with liver metastasis

Renal:

• Creatinine clearance of > 45 ml/ min (by Cockcroft-Gault)

Cardiovascular:

• No unstable or uncompensated cardiovascular conditions

Pulmonary:

• No unstable or uncompensated respiratory conditions

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pemetrexed (Alimta) in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer: A Hoosier Oncology Group Phase II Study (LUN04-78)
• Study Start Date: January 2005
• Actual Primary Completion Date: October 2005
• Actual Study Completion Date: October 2005

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1; Pemetrexed for patients with chemosensitive and chemoresistant relapsed small cell lung cancer.	Drug: Pemetrexed; Pemetrexed 500 mg/m2 IV q 3 weeks

Outcome Measures

Primary Outcome Measures :

1. - To estimate the clinical benefit rate (CR, PR, SD) of pemetrexed in two patient populations with small cell lung cancer: chemosensitive and chemoresistant relapsed independently. [ Time Frame: 12 months ]

Secondary Outcome Measures :

1. To determine the toxicity of pemetrexed; To estimate the time to disease progression; To estimate overall survival [ Time Frame: 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Histological or cytological proof of neuroendocrine cancers (including small cell cancers of any site [including lung] or poorly differentiated neuroendocrine cancers of the lung with (unidimensionally) measurable disease as per the RECIST criteria
• Chemoresistant or chemosensitive disease
• Patients must have received treatment with at least one but not more than 2 prior chemotherapy regimens, including one regimen containing a platinum agent
• Radiation therapy must have completed their radiation at least 14 days prior to being registered for protocol therapy, and toxicities due to radiation must have recovered to < grade 1 or baseline prior to registration
• Negative pregnancy test

Exclusion Criteria:

• No clinically significant infections as judged by the treating investigator
• No symptomatic CNS metastasis
• No radiation to > 25% of the marrow containing spaces
• No previous treatment with pemetrexed
• No uncontrolled pleural effusions
• No current breastfeeding

Contacts and Locations

Locations

United States, Delaware

Helen F. Graham Cancer Center

Newark, Delaware, United States, 19713

United States, Illinois

Medical & Surgical Specialists, LLC

Galesburg, Illinois, United States, 61401

United States, Indiana

Elkhart Clinic

Elkhart, Indiana, United States, 46515

Oncology Hematology Associates of SW Indiana

Evansville, Indiana, United States, 47714

Fort Wayne Oncology & Hematology, Inc

Fort Wayne, Indiana, United States, 46815

Center for Cancer Care at Goshen Health System

Goshen, Indiana, United States, 46527

Indiana University Cancer Center

Indianapolis, Indiana, United States, 46202

Community Regional Cancer Center

Indianapolis, Indiana, United States, 46256

Arnett Cancer Care

Lafayette, Indiana, United States, 47904

Medical Consultants, P.C.

Muncie, Indiana, United States, 47303

Center for Cancer Care, Inc., P.C.

New Albany, Indiana, United States, 47150

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States, 46601

Northern Indiana Oncology Associates

South Bend, Indiana, United States, 46617

AP&S Clinic

Terre Haute, Indiana, United States, 47804

United States, Missouri

Siteman Cancer Center

St. Louis, Missouri, United States, 63110

United States, Nebraska

Methodist Cancer Center

Omaha, Nebraska, United States, 68114

Sponsors and Collaborators

Hoosier Cancer Research Network

Eli Lilly and Company

Walther Cancer Institute

Investigators

• Study Chair: Nasser Hanna, M.D.; Hoosier Oncology Group, LLC

More Information

Additional Information:

Hoosier Oncology Group Home Page 

Publications of Results:

Jalal S, Ansari R, Govindan R, Bhatia S, Bruetman D, Fisher W, Masters G, White A, Stover D, Yu M, Hanna N; Hoosier Oncology Group. Pemetrexed in second line and beyond small cell lung cancer: a Hoosier Oncology Group phase II study. J Thorac Oncol. 2009 Jan;4(1):93-6. doi: 10.1097/JTO.0b013e31818de1e6.

• Responsible Party: Nasser Hanna, M.D., Hoosier Oncology Group
• ClinicalTrials.gov Identifier: NCT00216216
• Other Study ID Numbers: HOG LUN04-78
• First Posted: September 22, 2005
• Last Update Posted: May 2, 2011
• Last Verified: April 2011

Additional relevant MeSH terms:

Lung Neoplasms; Small Cell Lung Carcinoma; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pemetrexed; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors