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

Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00216216
• Other study ID #: HOG LUN04-78
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: April 28, 2011
• Start date: January 2005
• Est. completion date: October 2005

Study information

• Verified date: April 2011
• Source: Hoosier Cancer Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• Pemetrexed
Pemetrexed 500 mg/m2 IV q 3 weeks

Locations

Country	Name	City	State
United States	Elkhart Clinic	Elkhart	Indiana
United States	Oncology Hematology Associates of SW Indiana	Evansville	Indiana
United States	Fort Wayne Oncology & Hematology, Inc	Fort Wayne	Indiana
United States	Medical & Surgical Specialists, LLC	Galesburg	Illinois
United States	Center for Cancer Care at Goshen Health System	Goshen	Indiana
United States	Community Regional Cancer Center	Indianapolis	Indiana
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Arnett Cancer Care	Lafayette	Indiana
United States	Medical Consultants, P.C.	Muncie	Indiana
United States	Center for Cancer Care, Inc., P.C.	New Albany	Indiana
United States	Helen F. Graham Cancer Center	Newark	Delaware
United States	Methodist Cancer Center	Omaha	Nebraska
United States	Northern Indiana Cancer Research Consortium	South Bend	Indiana
United States	Northern Indiana Oncology Associates	South Bend	Indiana
United States	Siteman Cancer Center	St. Louis	Missouri
United States	AP&S Clinic	Terre Haute	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Hoosier Cancer Research Network	Eli Lilly and Company, Walther Cancer Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- 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	No
Secondary	To determine the toxicity of pemetrexed; To estimate the time to disease progression; To estimate overall survival		12 months	Yes

External Links

•   Hoosier Oncology Group Home Page