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An Extended Feasibility Phase I/II Study of Methylenetetrahydrofolate and Pemetrexed Single Agent, Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Rectal Cancer

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Trial Information

An Extended Feasibility Phase I/II Study of Methylenetetrahydrofolate and Pemetrexed Single Agent, Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer

Inclusion Criteria:

- Pathological/ cytological diagnosis of adenocarcinoma of the rectum. Patients must
have operable rectal cancer that is amenable to surgery.

- No prior therapy for rectal cancer

- Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1

- Adequate organ function

- Patient compliance and geographic proximity that allow adequate follow-up

- For women: Must be surgically sterile, postmenopausal, or compliant with a medically
approved contraceptive regimen during and for 3 months after treatment; must have a
negative serum or urine pregnancy test and must not be lactating.

- For men: Must be surgically sterile or compliant with a contraceptive regimen during
and for 3 months after treatment.

- Estimated life expectancy of at least 12 weeks

- Signed informed consent

- At least 18 years of age

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 (e.g., active infection including HIV, cardiac
disease) that in the opinion of the investigator would compromise the patient's
ability to complete the study.

- Have previously completed or withdrawn from this study or any other study
investigating pemetrexed.

- Are pregnant or breast-feeding.

- Second primary malignancy that is clinically detectable at the time of consideration
for study enrollment.

- History of significant neurological or mental disorder, including seizures or

- Inability to interrupt aspirin or other nonsteroidal anto-inflammatory drugs (NSAIDs)

- Presence of clinically relevant third-space fluid collection that cannot be
controlled by drainage or other procedures prior to study entry.

- Inability or unwillingness to be given 5,10-methylenetetrahydrofolate, vitamin B12 or

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of Pemetrexed Prior to Surgery

Outcome Description:

Feasibility is defined as the ability to receive the total planned dose of pemetrexed (i.e., 1500 mg/m) administered over a period of no more than 9 weeks. Feasibility is measured as absence of the following toxicities: CTC grade 4 lasting >= 7 days, or febrile neutropenia CTC grade 4 thrombocytopenia or grade 3 with bleeding. CTC grade 3 nonhematologic toxicity (excluding nausea and vomiting, isolated CTC grade 3 ALT or AST that returns to the patient's pretreatment CTC grade within 3 weeks, or grade 3 fatigue lasting <7 days).

Outcome Time Frame:

3 cycles (21-day cycles)

Safety Issue:


Principal Investigator

Bengt G Gustavsson, PhD, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sahlgrenska University Hospital, Sweden


Sweden: Medical Products Agency

Study ID:




Start Date:

April 2011

Completion Date:

Related Keywords:

  • Rectal Cancer
  • 5,10-methylenetetrahydrofolate
  • neoadjuvant therapy
  • pemetrexed
  • Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms
  • Intestinal Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Neoplasms by Site
  • Rectal Diseases
  • Digestive System Diseases
  • Gastrointestinal Diseases
  • Intestinal Diseases
  • Pemetrexed
  • Pharmacologic Actions
  • Therapeutic Uses
  • Antineoplastic Agents
  • Enzyme Inhibitors
  • Molecular Mechanisms of Pharmacological Action
  • Folic Acid Antagonists
  • Antimetabolites, Antineoplastic
  • Antimetabolites
  • Rectal Neoplasms