Clinical trial NCT00330915: A Study of Pemetrexed and Folic Acid Given Before Surgery (Neoadjuvant Treatment) to Patients With Rectal Cancer.
Official title: A Feasibility Study of Pemetrexed Single Agent and Folic Acid Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Neoplasms
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-05-29
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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* previously completed or withdrawn from this study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

Primary outcomes:
measure: Feasibility of Pemetrexed Prior to Surgery
timeFrame: 3 cycles (21-day cycles)
Secondary outcomes:
measure: Pathological Complete Response (pCR)
timeFrame: surgery following 3 cycles (21-day cycles) of chemotherapy
measure: Number of Participants With Complete Tumor Resection
timeFrame: surgery following 3 cycles (21-day cycles) of chemotherapy
measure: Number of Participants Receiving Sphincter Saving Surgery
timeFrame: surgery following 3 cycles (21-day cycles) of chemotherapy
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/ GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: