A Feasibility study of Pemetrexed single agent and folic acid given as neoadjuvant treatment in patients with resectable rectal cancer - N/A

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-005929-62-SE
• Date of registration: 06/03/2006
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company Limited
• Public title: A Feasibility study of Pemetrexed single agent and folic acid given as neoadjuvant treatment in patients with resectable rectal cancer - N/A
• Scientific title: A Feasibility study of Pemetrexed single agent and folic acid given as neoadjuvant treatment in patients with resectable rectal cancer - N/A
• Date of first enrolment: 22/05/2006
• Target sample size: 40
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005929-62
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

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 S077.2).

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 (? ULN), alkaline phosphatase (ALP), aspartate transaminase (AST) and alanine transaminase (ALT) ?3.0 ? ULN).
renal: calculated creatinine clearance (CrCl) ?45 mL/min by using the standard Cockcroft and Gault formula (see Protocol Attachment S077.3). 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, including consent to collection of tissue and blood samples as specified by the protocol.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
10. Concurrent administration of any other anti-tumor therapy
11. Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
12. 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
13. Have previously completed or withdrawn from this study or any other study investigating Pemetrexed
14. Are pregnant or breast feeding
15. Second primary malignancy that is clinically detectable at the time of consideration for study enrollment
16. History of significant neurological or mental disorder, including seizures or dementia
17. Inability to interrupt aspirin or other nonsteroidal 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.
18. 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
19. Inability or unwillingness to take folic acid, vitamin B12, or dexamethasone



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

neoadjuvant treatment in chemo-naive patients with newly diagnosed operable rectal cancer
MedDRA version: 8.0 Level: LLT Classification code 10038038

Intervention(s)

Trade Name: ALIMTA
Product Name: ALIMTA
Product Code: LY231514
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: pemetrexed
CAS Number: 150399-23-8
Current Sponsor code: LY231514 disodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-

Trade Name: Behepan
Pharmaceutical Form: Injection*
INN or Proposed INN: hydroxokobalamin
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-

Trade Name: Vitamineral Familj
Pharmaceutical Form: Tablet
INN or Proposed INN: folic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.4-

Primary Outcome(s)

Main Objective: To evaluate the feasibility of three neo-adjuvant cycles of single agent Pemetrexed at 500 mg/m2 q3w prior to surgery with or without radiotherapy in patients with resectable rectal cancer.

Primary end point(s): The primary objective of feasibility will be explored by evaluating the proportion of patients who receive the planned total dose as defined above.
The proportion of patients who receive the planned total dose will be reported, including a 95% confidence interval. The estimate of this proportion will be given by
Feasibility rate = Number of patients who received the planned total dose/
Number of patients qualified for feasibility analysis

Secondary Objective: • Pathological response rate (pCR)
• Proportion of patients with sphincter saving surgery
• Proportion of patients with complete tumor resection rate (CTRR)
• Evaluation of qualitative and quantitative toxicities
• mTHF tissue levels, comparisons of before vs. after folic acid dosing and tumor vs. normal tissue.
• Correlation between mTHF and plasma Hcy levels.
• Correlation of folate gene polymorphisms and micro array signature profiles with clinical outcome and toxicity profiles

Secondary ID(s)

H3E-MC-S077