A Study of Pemetrexed and Folic Acid Given Before Surgery (Neoadjuvant Treatment) to Patients With Rectal Cancer.
NCT ID: NCT00330915
Last Updated: 2009-07-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
37 participants
INTERVENTIONAL
2006-06-30
2008-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pemetrexed Plus a Comparator Versus a Combination of 2 Comparators in First-Line Treatment of Colorectal Cancer
NCT00079872
Pemetrexed Alone as Salvage Treatment in Metastatic Colorectal Cancer Patients Who Were Failed After Standard Chemotherapy: A Phase II Single Arm Prospective Study
NCT02588781
Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations
NCT01109615
A Study of the Combination of Pemetrexed and Irinotecan Every Two Weeks in Metastatic Colorectal Cancer
NCT00191984
Pemetrexed Plus Tarceva as Salvage Treatment in EGFR Overexpressed Metastatic Colorectal Cancer Patients Who Were Failed After Standard Chemotherapy
NCT03086538
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 3 cycles
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 3 cycles
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eli Lilly and Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Eli Lilly
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
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
Eli Lilly and Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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.
Gothenburg, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H3E-MC-S077
Identifier Type: -
Identifier Source: secondary_id
9732
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.