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


Phase 2
18 Years
N/A
Not Enrolling
Both
Small Cell Lung Cancer

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome 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.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Nasser Hanna, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group, LLC

Authority:

United States: Institutional Review Board

Study ID:

HOG LUN04-78

NCT ID:

NCT00216216

Start Date:

January 2005

Completion Date:

October 2005

Related Keywords:

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

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Siteman Cancer CenterSaint Louis, Missouri  63110
Center for Cancer Care at Goshen Health SystemGoshen, Indiana  46526
Helen F. Graham Cancer CenterNewark, Delaware  19713
Methodist Cancer CenterOmaha, Nebraska  68114
Arnett Cancer CareLafayette, Indiana  47904
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Medical & Surgical Specialists, LLCGalesburg, Illinois  61401
Northern Indiana Oncology AssociatesSouth Bend, Indiana  46617
Oncology Hematology Associates of SW IndianaEvansville, Indiana  47714
Elkhart ClinicElkhart, Indiana  46515
Community Regional Cancer CenterIndianapolis, Indiana  46256
Medical Consultants, P.C.Muncie, Indiana  47303
Center for Cancer Care, Inc., P.C.New Albany, Indiana  47150
AP&S ClinicTerre Haute, Indiana  47804
Fort Wayne Oncology & Hematology, IncFort Wayne, Indiana  46815