Clinical trial NCT00216216: Pemetrexed in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Lead sponsor: Hoosier Cancer Research Network
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: Walther Cancer Institute
First posted: 2005-09-22
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility 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

Primary outcomes:
measure: - 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.
timeFrame: 12 months
Secondary outcomes:
measure: To determine the toxicity of pemetrexed; To estimate the time to disease progression; To estimate overall survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Newark
country: United States
facility: Helen F. Graham Cancer Center
state: Delaware
city: Galesburg
country: United States
facility: Medical & Surgical Specialists, LLC
state: Illinois
city: Elkhart
country: United States
facility: Elkhart Clinic
state: Indiana
city: Evansville
country: United States
facility: Oncology Hematology Associates of SW Indiana
state: Indiana
city: Fort Wayne
country: United States
facility: Fort Wayne Oncology & Hematology, Inc
state: Indiana
city: Goshen
country: United States
facility: Center for Cancer Care at Goshen Health System
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Community Regional Cancer Center
state: Indiana
city: Lafayette
country: United States
facility: Arnett Cancer Care
state: Indiana
city: Muncie
country: United States
facility: Medical Consultants, P.C.
state: Indiana
city: New Albany
country: United States
facility: Center for Cancer Care, Inc., P.C.
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Cancer Research Consortium
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Oncology Associates
state: Indiana
city: Terre Haute
country: United States
facility: AP&S Clinic
state: Indiana
city: St. Louis
country: United States
facility: Siteman Cancer Center
state: Missouri
city: Omaha
country: United States
facility: Methodist Cancer Center
state: Nebraska
Study officials:
affiliation: Hoosier Oncology Group, LLC
name: Nasser Hanna, M.D.
role: STUDY_CHAIR
References:
citation: 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.