Ovarian Cancer, Peritoneal Cancer
Conditions
Brief summary
The primary purpose of this trial is to estimate the drug effect on tumors in patients with ovarian or primary peritoneal cancers. Patients will receive Pemetrexed every 21 days until disease progression or unacceptable toxicity. This medication will be given over 10 minutes and may be administered intravenously (IV), through a vein in your arm. Vitamin supplementation is a required part of this study.
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
* Histologically confirmed recurrent or persistent disease ovarian epithelial or primary peritoneal cancer * Measurable disease * Must have received 1 prior platinum-based (carboplatin, cisplatin, or another organoplatinum compound) chemotherapy regimen for primary disease. Patients who had not received prior paclitaxel may have received a second regimen that included paclitaxel * Treatment-free interval \< 6 months after prior platinum-based therapy OR progressed during platinum-based therapy * Not eligible for a higher priority Gynecologic Oncology Group (GOG) protocol (i.e., any active phase III GOG protocol for the same patient population)
Exclusion criteria
* Patients who have had prior therapy with pemetrexed * Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy. * Patients who have received radiation to more than 25% of marrow
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response | baseline to measured progressive disease (up to 44 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 | every 21-day cycle up to 5 year follow-up | 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. |
| Duration of Response | time of initial response until documented tumor progression (up to 44 months) | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. |
| Progression-Free Survival | baseline until documented tumor progression (up to 44 months) | Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. |
| Overall Survival | baseline until death from any cause up to 5-year follow-up | Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pemetrexed Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression | 48 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Entry Criteria Not Met | 2 |
| Overall Study | Inevaluable (Never Treated) | 1 |
Baseline characteristics
| Characteristic | Pemetrexed |
|---|---|
| Age, Customized 40-49 years | 6 participants |
| Age, Customized <40 years | 1 participants |
| Age, Customized 50-59 years | 14 participants |
| Age, Customized 60-69 years | 14 participants |
| Age, Customized 70-79 years | 11 participants |
| Age, Customized >79 years | 2 participants |
| Cell Type Adenocarcinoma, Unspecified | 1 participants |
| Cell Type Clear Cell | 5 participants |
| Cell Type Endometrioid | 1 participants |
| Cell Type Mixed Epithelial | 6 participants |
| Cell Type Serous | 34 participants |
| Cell Type Undifferentiated Carcinoma | 1 participants |
| Gynecologic Oncology Group Performance Status 0 - Fully active | 30 participants |
| Gynecologic Oncology Group Performance Status 1 - Ambulatory, Restricted Strenuous Activity | 15 participants |
| Gynecologic Oncology Group Performance Status 2 - Ambulatory, No Work Activities | 3 participants |
| Prior Chemotherapy No | 0 participants |
| Prior Chemotherapy Yes | 48 participants |
| Prior Radiotherapy No | 47 participants |
| Prior Radiotherapy Yes | 1 participants |
| Race/Ethnicity Black | 1 participants |
| Race/Ethnicity White | 47 participants |
| Region of Enrollment United States | 48 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 0 Participants |
| Tumor Grade 1 - Well-Differentiated | 1 participants |
| Tumor Grade 2 - Moderately Differentiated | 15 participants |
| Tumor Grade 3 - Poorly Differentiated | 31 participants |
| Tumor Grade Unspecified | 1 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 47 / 48 |
| serious Total, serious adverse events | 12 / 48 |
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 44 months)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed | Tumor Response | Partial Response | 9 participants |
| Pemetrexed | Tumor Response | Stable Disease | 17 participants |
| Pemetrexed | Tumor Response | Inevaluable | 3 participants |
| Pemetrexed | Tumor Response | Complete Response | 1 participants |
| Pemetrexed | Tumor Response | Progressive Disease | 18 participants |
Comparison: Overall Response Rate is the total percentage of participants with either a complete response or a partial response (CR+PR)/48 X 100.95% CI: [10.5, 35]
Secondary
Duration of Response
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Time frame: time of initial response until documented tumor progression (up to 44 months)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pemetrexed | Duration of Response | 8.4 months |
Secondary
Number of Participants With Adverse Events by Grade
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 5 year follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed | Number of Participants With Adverse Events by Grade | Dermatologic - Grade 3 | 3 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Dermatologic - Grade 2 | 10 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Leukopenia - Grade 1 | 11 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Leukopenia - Grade 2 | 13 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Anemia - Grade 1 | 14 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Anemia - Grade 2 | 17 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Anemia - Grade 3 | 7 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Anemia - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Transfusion - Grade 1 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Transfusion - Grade 2 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Transfusion - Grade 3 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Gastrointestinal - Grade 1 | 14 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Gastrointestinal - Grade 2 | 14 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Nausea/vomiting - Grade 2 | 7 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Nausea/vomiting - Grade 3 | 4 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Nausea/vomiting - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Genitourinary - Grade 1 | 4 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Hepatic - Grade 1 | 2 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Hepatic - Grade 2 | 2 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Hepatic - Grade 3 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Dermatologic - Grade 1 | 10 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Neurologic - Grade 1 | 12 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Neurologic - Grade 2 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Constitutional - Grade 1 | 17 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Constitutional - Grade 2 | 14 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Pain - Grade 3 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Auditory - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Lymphatics - Grade 1 | 4 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Leukopenia - Grade 3 | 11 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Leukopenia - Grade 4 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Thrombocytopenia - Grade 1 | 15 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Thrombocytopenia - Grade 2 | 5 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Thrombocytopenia - Grade 3 | 2 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Thrombocytopenia - Grade 4 | 4 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Neutropenia - Grade 1 | 9 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Neutropenia - Grade 2 | 6 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Neutropenia - Grade 3 | 11 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Neutropenia - Grade 4 | 9 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Transfusion - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Coagulation - Grade 1 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Coagulation - Grade 2 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Coagulation - Grade 3 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Coagulation - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Gastrointestinal - Grade 3 | 4 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Gastrointestinal - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Nausea/vomiting - Grade 1 | 15 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Genitourinary - Grade 2 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Genitourinary - Grade 3 | 2 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Genitourinary - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Hepatic - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Alopecia - Grade 1 | 7 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Alopecia - Grade 2 | 5 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Dermatologic - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Neurologic - Grade 3 | 4 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Neurologic - Grade 4 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | SGOT - Grade 1 | 9 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | SGOT - Grade 2 | 4 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | SGOT - Grade 3 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | SGOT - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Alkaline phosphatase - Grade 1 | 3 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Alkaline phosphatase - Grade 2 | 3 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Alkaline phosphatase - Grade 3 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Alkaline phosphatase - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Ocular - Grade 1 | 2 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Ocular - Grade 2 | 3 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Ocular - Grade 3 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Ocular - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Hemorrhage - Grade 1 | 2 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Hemorrhage - Grade 2 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Hemorrhage - Grade 3 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Hemorrhage - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Pulmonary - Grade 1 | 4 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Pulmonary - Grade 2 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Pulmonary - Grade 3 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Pulmonary - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Lymphopenia - Grade 1 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Lymphopenia - Grade 2 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Lymphopenia - Grade 3 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Lymphopenia - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Constitutional - Grade 3 | 5 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Constitutional - Grade 4 | 2 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Metabolic - Grade 1 | 20 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Metabolic - Grade 2 | 9 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Metabolic - Grade 3 | 4 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Metabolic - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Cardiovascular - Grade 1 | 3 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Cardiovascular - Grade 2 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Cardiovascular - Grade 3 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Cardiovascular - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Pain - Grade 1 | 8 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Pain - Grade 2 | 6 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Pain - Grade 4 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Infection - Grade 1 | 2 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Infection - Grade 2 | 5 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Infection - Grade 3 | 5 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Infection - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Auditory - Grade 1 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Auditory - Grade 2 | 2 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Auditory - Grade 3 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Lymphatics - Grade 2 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Lymphatics - Grade 3 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Lymphatics - Grade 4 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Endocrine - Grade 1 | 2 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Endocrine - Grade 2 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Endocrine - Grade 3 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Endocrine - Grade 4 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Allergy - Grade 1 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Allergy - Grade 2 | 1 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Allergy - Grade 3 | 0 participants |
| Pemetrexed | Number of Participants With Adverse Events by Grade | Allergy - Grade 4 | 0 participants |
Secondary
Overall Survival
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Time frame: baseline until death from any cause up to 5-year follow-up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pemetrexed | Overall Survival | 11.4 months |
Secondary
Progression-Free Survival
Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.
Time frame: baseline until documented tumor progression (up to 44 months)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pemetrexed | Progression-Free Survival | 3.0 months |