A Study of Pemetrexed and Folic Acid Given Before Surgery (Neoadjuvant Treatment) to Patients With Rectal Cancer.

Rectal Neoplasms Clinical Trial

Official title:

A Feasibility Study of Pemetrexed Single Agent and Folic Acid Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00330915
• Other study ID #: 9732
• Secondary ID: H3E-MC-S077
• Status: Completed
• Phase: Phase 2
• First received: May 26, 2006
• Last updated: June 3, 2009
• Start date: June 2006
• Est. completion date: June 2008

Study information

• Verified date: June 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to help answer the following research questions:

If the study drug Pemetrexed can help patients with rectal cancer; If molecular biological parameters are correlated respectively changing due to cytotoxic treatment with Pemetrexed; To evaluate adverse events

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• no prior therapy for rectal cancer

• pathological/ cytological diagnosis of adenocarcinoma of the rectum. Patients must have operable rectal cancer that is amenable to surgery.

• adequate organ function

• Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1

• signed informed consent

• at least 18 years of age

• surgically sterile, postmenopausal (women) or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment.

Exclusion Criteria:

• concurrent administration of any other anti-tumor therapy

• treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry

• serious concomitant systemic disorders

• previously completed or withdrawn from this study

• pregnant or breast-feeding

• second primary malignancy

• history of significant neurological or mental disorder, including seizures or dementia

• inability to interrupt aspirin or other nonsteroidal anto-inflammatory drugs (NSAIDs)

• presence of clinically relevant third space fluid collections that cannot be controlled by drainage or other procedure prior to the study entry

• inability or unwillingness to take folic acid, vitamin B12 or dexamethasone

Study Design

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

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

Drug:
• pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 3 cycles

Locations

Country	Name	City	State
Sweden	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Pemetrexed Prior to Surgery		3 cycles (21-day cycles)	Yes
Secondary	Pathological Complete Response (pCR)		surgery following 3 cycles (21-day cycles) of chemotherapy	No
Secondary	Number of Participants With Complete Tumor Resection		surgery following 3 cycles (21-day cycles) of chemotherapy	No
Secondary	Number of Participants Receiving Sphincter Saving Surgery		surgery following 3 cycles (21-day cycles) of chemotherapy	No

External Links

•   Lilly Clinical Trial Registry