Rectal Neoplasms
Conditions
Brief summary
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
Interventions
DRUGpemetrexed
500 mg/m2, intravenous (IV), every 21 days x 3 cycles
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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for any indication at the time of study entry * serious concomitant systemic disorders * previously completed or withdrawn from this study * pregnant or breast-feeding * second primary malignancy * history of significant neurological or mental disorder, including seizures or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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Pemetrexed Prior to Surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response (pCR) | surgery following 3 cycles (21-day cycles) of chemotherapy | Pathological complete response was defined as the absence of any tumor cells. |
| Number of Participants With Complete Tumor Resection | surgery following 3 cycles (21-day cycles) of chemotherapy | — |
| Number of Participants Receiving Sphincter Saving Surgery | surgery following 3 cycles (21-day cycles) of chemotherapy | — |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pemetrexed 500 mg/m2, intravenous (IV), every 21 days x 3 cycles | 37 |
| Total | 37 |
Baseline characteristics
| Characteristic | Pemetrexed |
|---|---|
| Age Continuous | 60.3 years STANDARD_DEVIATION 11.5 |
| Blood Pressure Diastolic Blood Pressure | 77.6 mm Hg STANDARD_DEVIATION 9.1 |
| Blood Pressure Systolic Blood Pressure | 136.5 mm Hg STANDARD_DEVIATION 18.4 |
| Body Height | 173.4 centimeters STANDARD_DEVIATION 9.4 |
| Body Surface Area | 2.0 meter squared STANDARD_DEVIATION 0.2 |
| Body Weight | 80.4 kilograms STANDARD_DEVIATION 15.2 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - Fully Active | 37 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1 - Ambulatory, Restricted Strenuous Activity | 0 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 2 - Ambulatory, No Work Activities | 0 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 3 - Partially Confined to Bed, Limited Self Care | 0 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 4 - Completely Disabled | 0 participants |
| Heart Rate | 80.4 beats per minute STANDARD_DEVIATION 14.8 |
| Histopathological Diagnosis G1 - Well-Differentiated | 3 participants |
| Histopathological Diagnosis G2 - Moderately Differentiated | 25 participants |
| Histopathological Diagnosis G3 - Poorly Differentiated | 3 participants |
| Histopathological Diagnosis Not Applicable | 4 participants |
| Histopathological Diagnosis Unspecified | 2 participants |
| Race/Ethnicity Caucasian | 36 participants |
| Race/Ethnicity East Asian | 1 participants |
| Region of Enrollment Sweden | 37 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 26 Participants |
| Time Since Initial Pathological Diagnosis | 3.2 weeks STANDARD_DEVIATION 1.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 37 / — |
| serious Total, serious adverse events | 17 / — |
Outcome results
Primary
Feasibility of Pemetrexed Prior to Surgery
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.
Time frame: 3 cycles (21-day cycles)
Population: Number of participants enrolled.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed | Feasibility of Pemetrexed Prior to Surgery | Feasibility - Yes | 33 participants |
| Pemetrexed | Feasibility of Pemetrexed Prior to Surgery | Feasibility - No | 4 participants |
Secondary
Number of Participants Receiving Sphincter Saving Surgery
Time frame: surgery following 3 cycles (21-day cycles) of chemotherapy
Population: Number of participants enrolled.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed | Number of Participants Receiving Sphincter Saving Surgery | Surgery - Yes | 25 participants |
| Pemetrexed | Number of Participants Receiving Sphincter Saving Surgery | Surgery - No | 12 participants |
Secondary
Number of Participants With Complete Tumor Resection
Time frame: surgery following 3 cycles (21-day cycles) of chemotherapy
Population: Number of participants enrolled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pemetrexed | Number of Participants With Complete Tumor Resection | 37 participants |
Secondary
Pathological Complete Response (pCR)
Pathological complete response was defined as the absence of any tumor cells.
Time frame: surgery following 3 cycles (21-day cycles) of chemotherapy
Population: Number of participants enrolled.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed | Pathological Complete Response (pCR) | Complete Response - No | 1 participants |
| Pemetrexed | Pathological Complete Response (pCR) | Complete Response - Yes | 0 participants |
| Pemetrexed | Pathological Complete Response (pCR) | Complete Response - Not Determined | 36 participants |