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

Pemetrexed (Alimta) in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer: A Hoosier Oncology Group Phase II Study (LUN04-78)

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

Study Overview

• Status: Terminated
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: Pemetrexed

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19713
      • Helen F. Graham Cancer Center
  • Illinois
    • Galesburg, Illinois, United States, 61401
      • Medical & Surgical Specialists, LLC
  • Indiana
    • Elkhart, Indiana, United States, 46515
      • Elkhart Clinic
    • Evansville, Indiana, United States, 47714
      • Oncology Hematology Associates of SW Indiana
    • Fort Wayne, Indiana, United States, 46815
      • Fort Wayne Oncology & Hematology, Inc
    • Goshen, Indiana, United States, 46527
      • Center for Cancer Care at Goshen Health System
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Cancer Center
    • Indianapolis, Indiana, United States, 46256
      • Community Regional Cancer Center
    • Lafayette, Indiana, United States, 47904
      • Arnett Cancer Care
    • Muncie, Indiana, United States, 47303
      • Medical Consultants, P.C.
    • New Albany, Indiana, United States, 47150
      • Center for Cancer Care, Inc., P.C.
    • South Bend, Indiana, United States, 46601
      • Northern Indiana Cancer Research Consortium
    • South Bend, Indiana, United States, 46617
      • Northern Indiana Oncology Associates
    • Terre Haute, Indiana, United States, 47804
      • AP&S Clinic
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Siteman Cancer Center
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Methodist Cancer Center

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
- 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.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine the toxicity of pemetrexed; To estimate the time to disease progression; To estimate overall survival	12 months

Collaborators and Investigators

• Sponsor: Hoosier Cancer Research Network
• Collaborators: Eli Lilly and Company; Walther Cancer Institute
• Investigators: Study Chair: Nasser Hanna, M.D., Hoosier Oncology Group, LLC

Publications and helpful links

General Publications

• 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.

Helpful Links

• Hoosier Oncology Group Home Page

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): October 1, 2005
• Study Completion (Actual): October 1, 2005

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 14, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): May 2, 2011
• Last Update Submitted That Met QC Criteria: April 28, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Folic Acid Antagonists; Pemetrexed
• Other Study ID Numbers: HOG LUN04-78