A Trial for Patients With Advanced/Recurrent Endometrial Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pemetrexed
|
Drug: pemetrexed
900 mg/m2, intravenous (IV), every 21 days, until disease progression
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gynecologic Oncology Group 215-854-0770 | Philadelphia | Pennsylvania | United States | 19103 |
Sponsors and Collaborators
- Eli Lilly and Company
- Gynecologic Oncology Group
Investigators
- Study Chair: David Miller, MD, Gynecologic Oncology Group
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 8368
- H3E-US-JMGT
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Pemetrexed |
|---|---|
| Arm/Group Description | 900 mg/m2, intravenous (IV), every 21 days, until disease progression |
| Period Title: Overall Study | |
| STARTED | 27 |
| COMPLETED | 26 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | Pemetrexed |
|---|---|
| Arm/Group Description | 900 mg/m2, intravenous (IV), every 21 days, until disease progression |
| Overall Participants | 26 |
| Age, Customized (participants) [Number] | |
| 40-49 years |
3
11.5%
|
| 50-59 years |
6
23.1%
|
| 60-69 years |
10
38.5%
|
| >69 years |
7
26.9%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
26
100%
|
| Male |
0
0%
|
| Race/Ethnicity, Customized (participants) [Number] | |
| White |
22
84.6%
|
| Black |
3
11.5%
|
| Asian |
1
3.8%
|
| Region of Enrollment (participants) [Number] | |
| United States |
26
100%
|
| Grade (Histology) (participants) [Number] | |
| G1 - Well-Differentiated |
5
19.2%
|
| G2 - Moderately Differentiated |
8
30.8%
|
| G3 - Poorly Differentiated |
13
50%
|
| Gynecologic Oncology Group (GOG) Performance Status (participants) [Number] | |
| 0 - Fully active |
14
53.8%
|
| 1 - Ambulatory, Restricted Strenuous Activity |
12
46.2%
|
| Prior Treatment (participants) [Number] | |
| Prior Chemotherapy |
26
100%
|
| No Prior Chemotherapy |
0
0%
|
| Prior Radiotherapy |
12
46.2%
|
| No Prior Radiotherapy |
14
53.8%
|
Outcome Measures
| Title | Tumor Response |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Pemetrexed |
|---|---|
| Arm/Group Description | 900 mg/m2, intravenous (IV), every 21 days, until disease progression |
| Measure Participants | 26 |
| Completed Response |
0
0%
|
| Partial Response |
1
3.8%
|
| Stable Disease |
12
46.2%
|
| Progressive Disease |
11
42.3%
|
| Inevaluable |
2
7.7%
|
| Title | Number of Participants With Adverse Events by Grade (Measures of Toxicity) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Pemetrexed |
|---|---|
| Arm/Group Description | 900 mg/m2, intravenous (IV), every 21 days, until disease progression |
| Measure Participants | 26 |
| Leukopenia - Grade 1 |
3
11.5%
|
| Leukopenia - Grade 2 |
4
15.4%
|
| Leukopenia - Grade 3 |
8
30.8%
|
| Leukopenia - Grade 4 |
2
7.7%
|
| Thrombocytopenia - Grade 1 |
7
26.9%
|
| Thrombocytopenia - Grade 2 |
1
3.8%
|
| Thrombocytopenia - Grade 3 |
4
15.4%
|
| Thrombocytopenia - Grade 4 |
0
0%
|
| Neutropenia - Grade 1 |
2
7.7%
|
| Neutropenia - Grade 2 |
3
11.5%
|
| Neutropenia - Grade 3 |
9
34.6%
|
| Neutropenia - Grade 4 |
3
11.5%
|
| Anemia - Grade 1 |
9
34.6%
|
| Anemia - Grade 2 |
11
42.3%
|
| Anemia - Grade 3 |
5
19.2%
|
| Anemia - Grade 4 |
0
0%
|
| Coagulation - Grade 1 |
0
0%
|
| Coagulation - Grade 2 |
0
0%
|
| Coagulation - Grade 3 |
1
3.8%
|
| Coagulation - Grade 4 |
0
0%
|
| Nausea/vomiting - Grade 1 |
5
19.2%
|
| Nausea/vomiting - Grade 2 |
2
7.7%
|
| Nausea/vomiting - Grade 3 |
2
7.7%
|
| Nausea/vomiting - Grade 4 |
0
0%
|
| Gastrointestinal - Grade 1 |
6
23.1%
|
| Gastrointestinal - Grade 2 |
6
23.1%
|
| Gastrointestinal - Grade 3 |
3
11.5%
|
| Gastrointestinal - Grade 4 |
0
0%
|
| Alopecia - Grade 1 |
1
3.8%
|
| Alopecia - Grade 2 |
0
0%
|
| Dermatologic - Grade 1 |
4
15.4%
|
| Dermatologic - Grade 2 |
2
7.7%
|
| Dermatologic - Grade 3 |
1
3.8%
|
| Dermatologic - Grade 4 |
0
0%
|
| Alkaline phosphatase - Grade 1 |
4
15.4%
|
| Alkaline phosphatase - Grade 2 |
0
0%
|
| Alkaline phosphatase - Grade 3 |
0
0%
|
| Alkaline phosphatase - Grade 4 |
0
0%
|
| Serum glutamic-oxaloacetic transaminase - Grade 1 |
3
11.5%
|
| Serum glutamic-oxaloacetic transaminase - Grade 2 |
0
0%
|
| Serum glutamic-oxaloacetic transaminase - Grade 3 |
0
0%
|
| Serum glutamic-oxaloacetic transaminase - Grade 4 |
0
0%
|
| Neurologic - Grade 1 |
6
23.1%
|
| Neurologic - Grade 2 |
3
11.5%
|
| Neurologic - Grade 3 |
0
0%
|
| Neurologic - Grade 4 |
1
3.8%
|
| Infection - Grade 1 |
0
0%
|
| Infection - Grade 2 |
4
15.4%
|
| Infection - Grade 3 |
2
7.7%
|
| Infection - Grade 4 |
0
0%
|
| Pulmonary - Grade 1 |
2
7.7%
|
| Pulmonary - Grade 2 |
0
0%
|
| Pulmonary - Grade 3 |
0
0%
|
| Pulmonary - Grade 4 |
0
0%
|
| Metabolic - Grade 1 |
7
26.9%
|
| Metabolic - Grade 2 |
1
3.8%
|
| Metabolic - Grade 3 |
0
0%
|
| Metabolic - Grade 4 |
0
0%
|
| Lymphatics - Grade 1 |
3
11.5%
|
| Lymphatics - Grade 2 |
0
0%
|
| Lymphatics - Grade 3 |
1
3.8%
|
| Lymphatics - Grade 4 |
0
0%
|
| Pain - Grade 1 |
3
11.5%
|
| Pain - Grade 2 |
2
7.7%
|
| Pain - Grade 3 |
3
11.5%
|
| Pain - Grade 4 |
0
0%
|
| Constitutional - Grade 1 |
4
15.4%
|
| Constitutional - Grade 2 |
8
30.8%
|
| Constitutional - Grade 3 |
5
19.2%
|
| Constitutional - Grade 4 |
0
0%
|
| Renal - Grade 1 |
1
3.8%
|
| Renal - Grade 2 |
0
0%
|
| Renal - Grade 3 |
0
0%
|
| Renal - Grade 4 |
0
0%
|
| Musculoskeletal - Grade 1 |
1
3.8%
|
| Musculoskeletal - Grade 2 |
1
3.8%
|
| Musculoskeletal - Grade 3 |
0
0%
|
| Musculoskeletal - Grade 4 |
0
0%
|
| Ocular - Grade 1 |
2
7.7%
|
| Ocular - Grade 2 |
1
3.8%
|
| Ocular - Grade 3 |
0
0%
|
| Ocular - Grade 4 |
0
0%
|
| Cardiovascular - Grade 1 |
1
3.8%
|
| Cardiovascular - Grade 2 |
1
3.8%
|
| Cardiovascular - Grade 3 |
0
0%
|
| Cardiovascular - Grade 4 |
0
0%
|
| Vascular - Grade 1 |
0
0%
|
| Vascular - Grade 2 |
0
0%
|
| Vascular - Grade 3 |
1
3.8%
|
| Vascular - Grade 4 |
0
0%
|
| Endocrine - Grade 1 |
0
0%
|
| Endocrine - Grade 2 |
1
3.8%
|
| Endocrine - Grade 3 |
0
0%
|
| Endocrine - Grade 4 |
0
0%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Pemetrexed | |
| Arm/Group Description | 900 mg/m2, intravenous (IV), every 21 days, until disease progression | |
All Cause Mortality |
||
| Pemetrexed | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Pemetrexed | ||
| Affected / at Risk (%) | # Events | |
| Total | 6/26 (23.1%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 2/26 (7.7%) | 2 |
| Febrile neutropenia | 1/26 (3.8%) | 1 |
| Thrombocytopenia | 1/26 (3.8%) | 1 |
| Gastrointestinal disorders | ||
| Gastrointestinal fistula | 1/26 (3.8%) | 1 |
| Metabolism and nutrition disorders | ||
| Dehydration | 1/26 (3.8%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Muscular weakness | 1/26 (3.8%) | 1 |
| Nervous system disorders | ||
| Ataxia | 1/26 (3.8%) | 1 |
| Syncope | 1/26 (3.8%) | 1 |
| Renal and urinary disorders | ||
| Renal failure acute | 1/26 (3.8%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Pemetrexed | ||
| Affected / at Risk (%) | # Events | |
| Total | 26/26 (100%) | |
| Blood and lymphatic system disorders | ||
| Anemia | 25/26 (96.2%) | |
| Leukopenia | 17/26 (65.4%) | |
| Lymphatics | 4/26 (15.4%) | |
| Neutropenia | 17/26 (65.4%) | |
| Thrombocytopenia | 12/26 (46.2%) | |
| Cardiac disorders | ||
| Cardiovascular | 2/26 (7.7%) | |
| Eye disorders | ||
| Ocular | 3/26 (11.5%) | |
| Gastrointestinal disorders | ||
| Gastrointestinal | 15/26 (57.7%) | |
| Nausea/vomiting | 9/26 (34.6%) | |
| General disorders | ||
| Constitutional | 17/26 (65.4%) | |
| Pain | 8/26 (30.8%) | |
| Infections and infestations | ||
| Infection | 6/26 (23.1%) | |
| Investigations | ||
| Alkaline phosphatase | 4/26 (15.4%) | |
| Serum glutamic-oxaloacetic transaminase | 3/26 (11.5%) | |
| Metabolism and nutrition disorders | ||
| Metabolic | 8/26 (30.8%) | |
| Musculoskeletal and connective tissue disorders | ||
| Musculoskeletal | 2/26 (7.7%) | |
| Nervous system disorders | ||
| Neurologic | 10/26 (38.5%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Pulmonary | 2/26 (7.7%) | |
| Skin and subcutaneous tissue disorders | ||
| Dermatologic | 7/26 (26.9%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 1-800-545-5979 |
- 8368
- H3E-US-JMGT