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

• Conditions: Resectable Rectal Cancer; MedDRA version: 16.0Level: LLTClassification code 10038045Term: Rectal cancer NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-009999-12-SE
• Lead Sponsor: ISOFOL Medical AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-13
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Pathological or cytological diagnosis of adenocarcinoma of the rectum. Patients must have operable rectal cancer that is amenable to curative surgery.

2. No prior therapy for rectal cancer.

3. Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status scale. (See Protocol Attachment S091.2).

4. Adequate organ function that includes the following indices:
- adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) =1.5 × 109/L, platelet count =100 × 109/L, and hemoglobin =9 g/dL.
- hepatic: bilirubin =1.5 times the upper limit of normal (x ULN), alkaline phosphatase (ALP), aspartate transaminase (AST) and alanine transaminase (ALT) =3.0 x ULN).
- renal: calculated creatinine clearance (CrCl) = 45 ml/min by using the standard Cockcroft and Gault formula (see Protocol Attachment S091.3). Creatinine clearance enrollment and dosing decisions may be made on the basis of either local lab values or central laboratory values (the central laboratory reports the calculated value directly). A patient may be enrolled on the basis of the local lab values.

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

6. 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 (within 7 days before enrolment) and must not be lactating.
For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after treatment.

7. Estimated life expectancy of at least 12 weeks.

8. Patients must sign an informed consent document.

9. Patients must be at least 18 years of age.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

1. Concurrent administration of any other anti-tumor therapy.

2. Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

3. 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.

4. Have previously completed or withdrawn from this study or any other study investigating Pemetrexed.

5. Are pregnant or breast-feeding.

6. Second primary malignancy except for basal-cell carcinoma and in situ carcinoma of the cervix, that is clinically detectable at the time of consideration for study enrollment.

7. History of significant neurological or mental disorder, including seizures or dementia.

8. Inability to interrupt aspirin or other no steroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of and 2 days after administration of Pemetrexed. If a patient is taking an NSAID or salicylate with a long half-life (e.g., Naproxen, Piroxicam, Diflunisal, Nabumetone, Refexocib, Celecoxib) it should not be taken 5 days before, the day of and 2 days after administration of Pemetrexed.

9. Presence of clinically relevant (i.e., detectable by physical examination) third-space fluid collection (e.g., ascites, pleural effusion) that cannot be controlled by drainage or other procedures prior to study entry.

10. Inability or unwillingness to be given Methylenetetrahydrofolate, vitamin B12 or Dexamethasone

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified