Phase 2
N=37
A Study of Pemetrexed and Folic Acid Given Before Surgery (Neoadjuvant Treatment) to Patients With Rectal Cancer.
Rectal Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00330915 ↗Enrolled (actual)
37
Serious AEs
—
Results posted
Jul 2009
Primary outcome: Primary: Feasibility of Pemetrexed Prior to Surgery — 33; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pemetrexed (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Pemetrexed Prior to Surgery |
33; 4 | — |
| SECONDARY Pathological Complete Response (pCR) |
0; 1; 36 | — |
| SECONDARY Number of Participants With Complete Tumor Resection |
37 | — |
| SECONDARY Number of Participants Receiving Sphincter Saving Surgery |
25; 12 | — |
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- previously completed or withdrawn from this study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
Data sourced from ClinicalTrials.gov (NCT00330915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.