Cancer of Endometrium, Cancer of the Endometrium, Endometrial Cancer, Endometrial Neoplasms, Endometrium Cancer, Genital Neoplasms, Female, Neoplasms, Neoplasms by Site, Neoplasms, Endometrial, Urogenital Neoplasms, Uterine Neoplasms
Conditions
Brief summary
The intent of this protocol is to screen a new agent for activity in patients with advanced or recurrent endometrial carcinoma. This phase II trial is studying how well pemetrexed disodium works in treating patients with advanced or recurrent endometrial carcinoma.
Interventions
DRUGpemetrexed
900 mg/m2, intravenous (IV), every 21 days, until disease progression
Sponsors
Gynecologic Oncology Group
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Patients must have recurrent or persistent endometrial adenocarcinoma, which is refractory to curative therapy or established treatments. * Patients must have measurable disease. * Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma. * Patients must have signed an approved informed consent. * Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception during the study and for at least 3 months following the last dose of Pemetrexed. * Patients must discontinue nonsteroidal anti-inflammatory (NSAIDs) medications 2-5 days prior to and for 1-2 days after receiving Pemetrexed, depending on the half-life of the NSAIDs treatment. * Patients must agree to this schedule in conjunction with every dose of Pemetrexed. * Patients must receive 350-1000 mcg of folic acid (e.g. one prenatal vitamin) starting 7 days prior to the first treatment with Pemetrexed. * Patients must be able to ingest 350-1000 mcg of folic acid daily until 3 weeks after the last dose of Pemetrexed. * Patients must receive 4 mg Dexamethasone by mouth twice daily, 1 day prior to the dose, the day of and the day after every dose of Pemetrexed. * Patients must receive a 1000 mcg vitamin B12 injection 7 days prior to receiving the first treatment with Pemetrexed. * Patients must agree to receive 1000 mcg vitamin B12 injection every 9 weeks until 3 weeks after the last dose of Pemetrexed.
Exclusion criteria
* Patients who have had prior therapy with Pemetrexed * Patients who have received radiation to more than 25% of marrow bearing areas
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response | baseline to measured progressive disease (up to 24 months) | Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. Complete response (CR) = disappearance of all target lesions; Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable disease (SD) = small changes that do not meet above criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events by Grade (Measures of Toxicity) | every 21-day cycle (up to 24 months) | Adverse events were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). The worst grade event per cycle is reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligible (Prior radiation) | 1 |
Baseline characteristics
| Characteristic | Pemetrexed |
|---|---|
| Age, Customized 40-49 years | 3 participants |
| Age, Customized 50-59 years | 6 participants |
| Age, Customized 60-69 years | 10 participants |
| Age, Customized >69 years | 7 participants |
| Grade (Histology) G1 - Well-Differentiated | 5 participants |
| Grade (Histology) G2 - Moderately Differentiated | 8 participants |
| Grade (Histology) G3 - Poorly Differentiated | 13 participants |
| Gynecologic Oncology Group (GOG) Performance Status 0 - Fully active | 14 participants |
| Gynecologic Oncology Group (GOG) Performance Status 1 - Ambulatory, Restricted Strenuous Activity | 12 participants |
| Prior Treatment No Prior Chemotherapy | 0 participants |
| Prior Treatment No Prior Radiotherapy | 14 participants |
| Prior Treatment Prior Chemotherapy | 26 participants |
| Prior Treatment Prior Radiotherapy | 12 participants |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Black | 3 participants |
| Race/Ethnicity, Customized White | 22 participants |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 26 / 26 |
| serious Total, serious adverse events | 6 / 26 |
Outcome results
Primary
Tumor Response
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. Complete response (CR) = disappearance of all target lesions; Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable disease (SD) = small changes that do not meet above criteria.
Time frame: baseline to measured progressive disease (up to 24 months)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed | Tumor Response | Completed Response | 0 participants |
| Pemetrexed | Tumor Response | Partial Response | 1 participants |
| Pemetrexed | Tumor Response | Stable Disease | 12 participants |
| Pemetrexed | Tumor Response | Progressive Disease | 11 participants |
| Pemetrexed | Tumor Response | Inevaluable | 2 participants |
Secondary
Number of Participants With Adverse Events by Grade (Measures of Toxicity)
Adverse events were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). The worst grade event per cycle is reported.
Time frame: every 21-day cycle (up to 24 months)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Renal - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Musculoskeletal - Grade 1 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Musculoskeletal - Grade 2 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Anemia - Grade 2 | 11 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Thrombocytopenia - Grade 1 | 7 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Leukopenia - Grade 1 | 3 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Leukopenia - Grade 2 | 4 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Leukopenia - Grade 3 | 8 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Leukopenia - Grade 4 | 2 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Thrombocytopenia - Grade 2 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Thrombocytopenia - Grade 3 | 4 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Thrombocytopenia - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Neutropenia - Grade 1 | 2 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Neutropenia - Grade 2 | 3 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Neutropenia - Grade 3 | 9 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Neutropenia - Grade 4 | 3 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Anemia - Grade 1 | 9 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Anemia - Grade 3 | 5 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Anemia - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Coagulation - Grade 1 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Coagulation - Grade 2 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Coagulation - Grade 3 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Coagulation - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Nausea/vomiting - Grade 1 | 5 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Nausea/vomiting - Grade 2 | 2 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Nausea/vomiting - Grade 3 | 2 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Nausea/vomiting - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Gastrointestinal - Grade 1 | 6 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Gastrointestinal - Grade 2 | 6 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Gastrointestinal - Grade 3 | 3 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Gastrointestinal - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Alopecia - Grade 1 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Alopecia - Grade 2 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Dermatologic - Grade 1 | 4 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Dermatologic - Grade 2 | 2 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Dermatologic - Grade 3 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Dermatologic - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Alkaline phosphatase - Grade 1 | 4 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Alkaline phosphatase - Grade 2 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Alkaline phosphatase - Grade 3 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Alkaline phosphatase - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Serum glutamic-oxaloacetic transaminase - Grade 1 | 3 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Serum glutamic-oxaloacetic transaminase - Grade 2 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Serum glutamic-oxaloacetic transaminase - Grade 3 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Serum glutamic-oxaloacetic transaminase - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Neurologic - Grade 1 | 6 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Neurologic - Grade 2 | 3 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Neurologic - Grade 3 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Neurologic - Grade 4 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Infection - Grade 1 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Infection - Grade 2 | 4 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Infection - Grade 3 | 2 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Infection - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Pulmonary - Grade 1 | 2 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Pulmonary - Grade 3 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Pulmonary - Grade 2 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Pulmonary - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Metabolic - Grade 1 | 7 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Metabolic - Grade 2 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Metabolic - Grade 3 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Metabolic - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Lymphatics - Grade 1 | 3 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Lymphatics - Grade 2 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Lymphatics - Grade 3 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Lymphatics - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Pain - Grade 1 | 3 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Pain - Grade 2 | 2 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Pain - Grade 3 | 3 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Pain - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Constitutional - Grade 1 | 4 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Constitutional - Grade 2 | 8 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Constitutional - Grade 3 | 5 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Constitutional - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Renal - Grade 1 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Renal - Grade 2 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Renal - Grade 3 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Musculoskeletal - Grade 3 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Musculoskeletal - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Ocular - Grade 1 | 2 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Ocular - Grade 2 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Ocular - Grade 3 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Ocular - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Cardiovascular - Grade 1 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Cardiovascular - Grade 2 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Cardiovascular - Grade 3 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Cardiovascular - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Vascular - Grade 1 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Vascular - Grade 2 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Vascular - Grade 3 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Vascular - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Endocrine - Grade 1 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Endocrine - Grade 2 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Endocrine - Grade 3 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade (Measures of Toxicity) | Endocrine - Grade 4 | 0 participants |