Pemetrexed in Patients With Advanced Neuroendocrine Tumors

Neuroendocrine Tumors Clinical Trial

Official title:

A Phase II Study of Pemetrexed in Patients With Advanced Neuroendocrine Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00424723
• Other study ID #: 05-309
• Status: Completed
• Phase: Phase 2
• First received: January 18, 2007
• Last updated: August 10, 2010
• Start date: December 2005
• Est. completion date: March 2010

Study information

• Verified date: August 2010
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out what effects (good and bad) pemetrexed has on patients with advanced neuroendocrine tumors.

Description:

• 1 cycle is equal to 21 days. Every 21 days the following will be performed: a review of the patients symptoms and medications; physical exam; blood tests; vital signs; and pemetrexed infusion.

• Every 3 cycles (9 weeks) an assessment of disease extent by CT scan and a 24 hour urine collection (if applicable) will be performed.

• Before patients start receiving pemetrexed, they will be given folic acid, vitamin B12 and dexamethasone to help reduce the chance of significant side effects. Dexamethasone will be taken the evening before, the morning before and the evening after receiving pemetrexed. Folic acid should be taken daily beginning 5-7 days before the first dose of pemetrexed and should be continued for three weeks after the last dose of pemetrexed. Vitamin B12 will be given as an injection 1-2 weeks before the first dose of pemetrexed and once every 9 weeks until 3 weeks after the last dose of pemetrexed.

• Patients can continue to receive treatment with pemetrexed unless there is evidence that their tumor has grown or they are experiencing serious side effects.

• Immediately after the patient has completed the study, they will be given a physical exam, including vital signs, a CT scan, and blood tets. The study staff will continue to monitor the patients health either by clinic visits or phone calls every three months for the remainder of your life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2010
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Metastatic or locally unresectable neuroendocrine tumor, excluding small cell carcinoma

• Measurable tumor

• 18 year of age or older

• ECOG performance status of 0,1 or 2

• Life expectancy of greater than 12 weeks

• WBC: > 3.0/mm3

• Plts: > 100,000/mm3

• Bilirubin: < 2.0 mg/dl

• AST < 3 x ULN (except in patients with known hepatic metastases wherein SST may be < 5 x ULN)

• Neutrophils > 1000/mm3

• Creatinine Clearance > 45 ml/min. Should be measured using the standard Cockroft-Gault formula

Exclusion Criteria:

• Prior treatment with pemetrexed

• Clinically apparent central nervous system metastases or carcinomatous meningitis

• Myocardial infarction in the past 6 months

• Major surgery in the past two weeks

• Uncontrolled serious medical or psychiatric illness

• Pregnant or lactating women

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

• Carcinoid Tumor
• Neuroendocrine Tumors

Intervention

Drug:
• Pemetrexed
Given intravenously over 10 minutes every 21 days (21 days equals one cycle). Subjects will continue to receive pemetrexed as long as their disease does not worsen and they do not experience any serious side effects.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Center	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chan JA, Zhu AX, Stuart K, Bhargava P, Earle CC, Clark JW, Casey C, Regan E, Kulke MH. Phase II study of pemetrexed in patients with advanced neuroendocrine tumors. Cancer Chemother Pharmacol. 2010 Oct;66(5):961-8. doi: 10.1007/s00280-010-1248-6. Epub 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the radiologic response rate associated with pemetrexed in patients with neuroendocrine tumors.		2 years	No
Secondary	To perform an analysis of the biochemical response rate		2 years	No
Secondary	to assess the toxicity associated with pemetrexed		2 years	Yes
Secondary	and to assess the progression-free and overall survival of patients.		TBD	No