Cervical Intraepithelial Neoplasia, Genital Neoplasms, Female, Uterine Neoplasms
Conditions
Brief summary
This phase II trial is studying the antitumor activity of single agent pemetrexed 900mg/m2 IV over 10 minutes in patients with recurrent cervical cancer.
Interventions
DRUGPemetrexed
Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes 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
* Recurrent squamous or non-squamous cell carcinoma of the cervix with documented disease progression * Measurable disease * Gynecologic Oncology Group (GOG) performance status 0-2 * Patients must have received one prior systemic chemotherapy for persistent or recurrent disease * Patients with mild to moderate renal insufficiency should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs\_ with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed. * All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration. * Folic Acid (350-1000 ug) must be given daily beginning approximately 5-7 days prior to first does of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy. * Vitamin B12 (1000 ug) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy
Exclusion criteria
* Prior Pemetrexed * Patients who have received radiation to more than 25% of marrow bearing areas * Any evidence of other malignancy within last 5 years, with exception of non-melanoma skin cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response | baseline to measured progressive disease (up to 5 years) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response | time of initial response until documented tumor progression (up to 5 years) | 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 5 years) | The period from study entry until disease progression, death or date of last contact. |
| Overall Survival | baseline until death from any cause (up to 5 years) | 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 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Inevaluable (never treated) | 2 |
Baseline characteristics
| Characteristic | Pemetrexed |
|---|---|
| Age, Customized 40-49 years | 9 participants |
| Age, Customized <40 years | 6 participants |
| Age, Customized 50-59 years | 7 participants |
| Age, Customized 60-69 years | 4 participants |
| Age, Customized >69 years | 1 participants |
| Cell Type Adenocarcinoma | 6 participants |
| Cell Type Adenosquamous | 1 participants |
| Cell Type Clear cell | 1 participants |
| Cell Type Squamous | 19 participants |
| Gynecologic Oncology Group (GOG) Performance Status 0 - Fully active | 16 participants |
| Gynecologic Oncology Group (GOG) Performance Status 1 - Ambulatory, Restricted Strenuous Activity | 9 participants |
| Gynecologic Oncology Group (GOG) Performance Status 2 - Ambulatory, No Work Activities | 2 participants |
| Prior Therapy No Prior Chemotherapy | 0 participants |
| Prior Therapy No Prior Radiotherapy | 4 participants |
| Prior Therapy Prior Chemotherapy | 27 participants |
| Prior Therapy Prior Radiotherapy | 23 participants |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Black | 2 participants |
| Race/Ethnicity, Customized White | 24 participants |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 0 Participants |
| Tumor Grade G1 - Well-Differentiated | 5 participants |
| Tumor Grade G2 - Moderately Differentiated | 15 participants |
| Tumor Grade G3 - Poorly Differentiated | 5 participants |
| Tumor Grade Unspecified | 2 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / — |
| serious Total, serious adverse events | 5 / — |
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.
Time frame: baseline to measured progressive disease (up to 5 years)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed | Tumor Response | Complete Response | 0 participants |
| Pemetrexed | Tumor Response | Partial Response | 4 participants |
| Pemetrexed | Tumor Response | Stable Disease | 16 participants |
| Pemetrexed | Tumor Response | Disease Progression | 7 participants |
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 5 years)
Population: All enrolled participants who had either a complete response (n=0) or partial response (n=4).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pemetrexed | Duration of Response | 4.4 months |
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 years)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pemetrexed | Overall Survival | 7.4 months |
Secondary
Progression-Free Survival
The period from study entry until disease progression, death or date of last contact.
Time frame: baseline until documented tumor progression (up to 5 years)
Population: All enrolled participants who experienced disease progression.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pemetrexed | Progression-Free Survival | 3.1 months |