Trial Outcomes & Findings for A Study of Pemetrexed and Folic Acid Given Before Surgery (Neoadjuvant Treatment) to Patients With Rectal Cancer. (NCT NCT00330915)
NCT ID: NCT00330915
Last Updated: 2009-07-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
3 cycles (21-day cycles)
Results posted on
2009-07-21
Participant Flow
Participant milestones
| Measure |
Pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 3 cycles
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Pemetrexed and Folic Acid Given Before Surgery (Neoadjuvant Treatment) to Patients With Rectal Cancer.
Baseline characteristics by cohort
| Measure |
Pemetrexed
n=37 Participants
500 mg/m2, intravenous (IV), every 21 days x 3 cycles
|
|---|---|
|
Age Continuous
|
60.3 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
37 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 - Fully Active
|
37 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
0 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2 - Ambulatory, No Work Activities
|
0 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
3 - Partially Confined to Bed, Limited Self Care
|
0 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
4 - Completely Disabled
|
0 participants
n=5 Participants
|
|
Histopathological Diagnosis
G1 - Well-Differentiated
|
3 participants
n=5 Participants
|
|
Histopathological Diagnosis
G2 - Moderately Differentiated
|
25 participants
n=5 Participants
|
|
Histopathological Diagnosis
G3 - Poorly Differentiated
|
3 participants
n=5 Participants
|
|
Histopathological Diagnosis
Not Applicable
|
4 participants
n=5 Participants
|
|
Histopathological Diagnosis
Unspecified
|
2 participants
n=5 Participants
|
|
Race/Ethnicity
Caucasian
|
36 participants
n=5 Participants
|
|
Race/Ethnicity
East Asian
|
1 participants
n=5 Participants
|
|
Blood Pressure
Systolic Blood Pressure
|
136.5 mm Hg
STANDARD_DEVIATION 18.4 • n=5 Participants
|
|
Blood Pressure
Diastolic Blood Pressure
|
77.6 mm Hg
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Body Height
|
173.4 centimeters
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Body Surface Area
|
2.0 meter squared
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Body Weight
|
80.4 kilograms
STANDARD_DEVIATION 15.2 • n=5 Participants
|
|
Heart Rate
|
80.4 beats per minute
STANDARD_DEVIATION 14.8 • n=5 Participants
|
|
Time Since Initial Pathological Diagnosis
|
3.2 weeks
STANDARD_DEVIATION 1.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 cycles (21-day cycles)Population: Number of participants enrolled.
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.
Outcome measures
| Measure |
Pemetrexed
n=37 Participants
500 mg/m2, intravenous (IV), every 21 days x 3 cycles
|
|---|---|
|
Feasibility of Pemetrexed Prior to Surgery
Feasibility - Yes
|
33 participants
|
|
Feasibility of Pemetrexed Prior to Surgery
Feasibility - No
|
4 participants
|
SECONDARY outcome
Timeframe: surgery following 3 cycles (21-day cycles) of chemotherapyPopulation: Number of participants enrolled.
Pathological complete response was defined as the absence of any tumor cells.
Outcome measures
| Measure |
Pemetrexed
n=37 Participants
500 mg/m2, intravenous (IV), every 21 days x 3 cycles
|
|---|---|
|
Pathological Complete Response (pCR)
Complete Response - Yes
|
0 participants
|
|
Pathological Complete Response (pCR)
Complete Response - No
|
1 participants
|
|
Pathological Complete Response (pCR)
Complete Response - Not Determined
|
36 participants
|
SECONDARY outcome
Timeframe: surgery following 3 cycles (21-day cycles) of chemotherapyPopulation: Number of participants enrolled.
Outcome measures
| Measure |
Pemetrexed
n=37 Participants
500 mg/m2, intravenous (IV), every 21 days x 3 cycles
|
|---|---|
|
Number of Participants With Complete Tumor Resection
|
37 participants
|
SECONDARY outcome
Timeframe: surgery following 3 cycles (21-day cycles) of chemotherapyPopulation: Number of participants enrolled.
Outcome measures
| Measure |
Pemetrexed
n=37 Participants
500 mg/m2, intravenous (IV), every 21 days x 3 cycles
|
|---|---|
|
Number of Participants Receiving Sphincter Saving Surgery
Surgery - Yes
|
25 participants
|
|
Number of Participants Receiving Sphincter Saving Surgery
Surgery - No
|
12 participants
|
Adverse Events
Pemetrexed
Serious events: 17 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 3 cycles
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
2.7%
1/37 • Number of events 1
|
|
Cardiac disorders
Myocardial ischaemia
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Ileus
|
13.5%
5/37 • Number of events 5
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
1/37 • Number of events 1
|
|
General disorders
Pyrexia
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Anorectal infection
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Infection
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Peritoneal abscess
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
2.7%
1/37 • Number of events 1
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
2.7%
1/37 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
2.7%
1/37 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.7%
1/37 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound complication
|
8.1%
3/37 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.7%
1/37 • Number of events 1
|
|
Vascular disorders
Haematoma
|
2.7%
1/37 • Number of events 1
|
|
Vascular disorders
Haemorrhage
|
2.7%
1/37 • Number of events 1
|
Other adverse events
| Measure |
Pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 3 cycles
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
5.4%
2/37 • Number of events 2
|
|
Eye disorders
Lacrimation increased
|
45.9%
17/37 • Number of events 18
|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
18.9%
7/37 • Number of events 7
|
|
Gastrointestinal disorders
Dry mouth
|
16.2%
6/37 • Number of events 6
|
|
Gastrointestinal disorders
Dyspepsia
|
8.1%
3/37 • Number of events 3
|
|
Gastrointestinal disorders
Frequent bowel movements
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
48.6%
18/37 • Number of events 23
|
|
General disorders
Fatigue
|
62.2%
23/37 • Number of events 33
|
|
General disorders
Mucosal inflammation
|
10.8%
4/37 • Number of events 5
|
|
General disorders
Pain
|
10.8%
4/37 • Number of events 5
|
|
General disorders
Pyrexia
|
16.2%
6/37 • Number of events 7
|
|
Investigations
Alanine aminotransferase increased
|
10.8%
4/37 • Number of events 4
|
|
Investigations
Haemoglobin decreased
|
5.4%
2/37 • Number of events 6
|
|
Investigations
Neutrophil count decreased
|
8.1%
3/37 • Number of events 5
|
|
Investigations
Weight decreased
|
5.4%
2/37 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
5.4%
2/37 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
18.9%
7/37 • Number of events 7
|
|
Nervous system disorders
Dysgeusia
|
5.4%
2/37 • Number of events 2
|
|
Nervous system disorders
Headache
|
18.9%
7/37 • Number of events 7
|
|
Renal and urinary disorders
Pollakiuria
|
5.4%
2/37 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.4%
2/37 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.4%
2/37 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
24.3%
9/37 • Number of events 14
|
|
Vascular disorders
Haemorrhage
|
5.4%
2/37 • Number of events 2
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60