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

Lilly

Status and phase

Completed

Phase 2

Conditions

Rectal Neoplasms

Treatments

Drug: pemetrexed

Study type

Interventional

Funder types

Industry

Identifiers

NCT00330915

H3E-MC-S077

9732

Details and patient eligibility

About

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

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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previously completed or withdrawn from this study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