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

NCT00330915 | Completed Phase 2 Results

• 2 other identifiers: 9732H3E-MC-S077
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Conditions

Rectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Feasibility of Pemetrexed Prior to Surgery

  Feasibility was defined as the ability to receive the total planned dose of Pemetrexed administered over a period of no more than 9 weeks permitting scheduling conflict. A ±5 percent variance in the calculated total dose was allowed.

  3 cycles (21-day cycles)

Secondary Outcomes (3)

• Pathological Complete Response (pCR)

  surgery following 3 cycles (21-day cycles) of chemotherapy

• Number of Participants With Complete Tumor Resection

  surgery following 3 cycles (21-day cycles) of chemotherapy

• Number of Participants Receiving Sphincter Saving Surgery

  surgery following 3 cycles (21-day cycles) of chemotherapy

Study Arms (1)

A

EXPERIMENTAL

Drug: pemetrexed

Interventions

pemetrexed DRUG

500 mg/m2, intravenous (IV), every 21 days x 3 cycles

Also known as: LY231514, Alimta

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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• previously completed or withdrawn from this study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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, 41685, Sweden

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 26, 2006
• First Posted: May 29, 2006
• Study Start: June 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 21, 2009
• Results First Posted: July 21, 2009

Record last verified: 2009-06

Locations

SE (1)