Pemetrexed in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer
Study Details
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 |
|---|---|---|
| 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
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
- - 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
- To determine the toxicity of pemetrexed; To estimate the time to disease progression; To estimate overall survival [12 months]
Eligibility Criteria
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
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Patients must have received treatment with at least one but not more than 2 prior chemotherapy regimens, including one regimen containing a platinum agent
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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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Helen F. Graham Cancer Center | Newark | Delaware | United States | 19713 |
| 2 | Medical & Surgical Specialists, LLC | Galesburg | Illinois | United States | 61401 |
| 3 | Elkhart Clinic | Elkhart | Indiana | United States | 46515 |
| 4 | Oncology Hematology Associates of SW Indiana | Evansville | Indiana | United States | 47714 |
| 5 | Fort Wayne Oncology & Hematology, Inc | Fort Wayne | Indiana | United States | 46815 |
| 6 | Center for Cancer Care at Goshen Health System | Goshen | Indiana | United States | 46527 |
| 7 | Indiana University Cancer Center | Indianapolis | Indiana | United States | 46202 |
| 8 | Community Regional Cancer Center | Indianapolis | Indiana | United States | 46256 |
| 9 | Arnett Cancer Care | Lafayette | Indiana | United States | 47904 |
| 10 | Medical Consultants, P.C. | Muncie | Indiana | United States | 47303 |
| 11 | Center for Cancer Care, Inc., P.C. | New Albany | Indiana | United States | 47150 |
| 12 | Northern Indiana Cancer Research Consortium | South Bend | Indiana | United States | 46601 |
| 13 | Northern Indiana Oncology Associates | South Bend | Indiana | United States | 46617 |
| 14 | AP&S Clinic | Terre Haute | Indiana | United States | 47804 |
| 15 | Siteman Cancer Center | St. Louis | Missouri | United States | 63110 |
| 16 | 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- HOG LUN04-78