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Completed

NCT Number: NCT00330915

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • previously completed or withdrawn from this study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

Treatment and study plan

Pemetrexed

Drug

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

Other names: LY231514, Alimta

Primary outcomes

  1. Feasibility of Pemetrexed Prior to Surgery

    Time frame: 3 cycles (21-day cycles)

    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.

Secondary outcomes

  1. Pathological Complete Response (pCR)

    Time frame: surgery following 3 cycles (21-day cycles) of chemotherapy

    Pathological complete response was defined as the absence of any tumor cells.

  2. Number of Participants With Complete Tumor Resection

    Time frame: surgery following 3 cycles (21-day cycles) of chemotherapy

  3. Number of Participants Receiving Sphincter Saving Surgery

    Time frame: surgery following 3 cycles (21-day cycles) of chemotherapy

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Feasibility Study of Pemetrexed Single Agent and Folic Acid Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 29, 2006
Registry last updated
Jul 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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