Trial Outcomes & Findings for A Trial for Patients With Advanced/Recurrent Cervical Cancer (NCT NCT00190983)
NCT ID: NCT00190983
Last Updated: 2009-11-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
baseline to measured progressive disease (up to 5 years)
Results posted on
2009-11-20
Participant Flow
Participant milestones
| Measure |
Pemetrexed
Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Pemetrexed
Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
|
|---|---|
|
Overall Study
Inevaluable (never treated)
|
2
|
Baseline Characteristics
A Trial for Patients With Advanced/Recurrent Cervical Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed
n=27 Participants
Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
|
|---|---|
|
Age, Customized
<40 years
|
6 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
9 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
7 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
4 participants
n=5 Participants
|
|
Age, Customized
>69 years
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
24 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
|
Cell Type
Squamous
|
19 participants
n=5 Participants
|
|
Cell Type
Adenocarcinoma
|
6 participants
n=5 Participants
|
|
Cell Type
Clear cell
|
1 participants
n=5 Participants
|
|
Cell Type
Adenosquamous
|
1 participants
n=5 Participants
|
|
Gynecologic Oncology Group (GOG) Performance Status
0 - Fully active
|
16 participants
n=5 Participants
|
|
Gynecologic Oncology Group (GOG) Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
9 participants
n=5 Participants
|
|
Gynecologic Oncology Group (GOG) Performance Status
2 - Ambulatory, No Work Activities
|
2 participants
n=5 Participants
|
|
Prior Therapy
Prior Chemotherapy
|
27 participants
n=5 Participants
|
|
Prior Therapy
No Prior Chemotherapy
|
0 participants
n=5 Participants
|
|
Prior Therapy
Prior Radiotherapy
|
23 participants
n=5 Participants
|
|
Prior Therapy
No Prior Radiotherapy
|
4 participants
n=5 Participants
|
|
Tumor Grade
G1 - Well-Differentiated
|
5 participants
n=5 Participants
|
|
Tumor Grade
G2 - Moderately Differentiated
|
15 participants
n=5 Participants
|
|
Tumor Grade
G3 - Poorly Differentiated
|
5 participants
n=5 Participants
|
|
Tumor Grade
Unspecified
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Pemetrexed
n=27 Participants
Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
|
|---|---|
|
Tumor Response
Complete Response
|
0 participants
|
|
Tumor Response
Partial Response
|
4 participants
|
|
Tumor Response
Stable Disease
|
16 participants
|
|
Tumor Response
Disease Progression
|
7 participants
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Pemetrexed
n=4 Participants
Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
|
|---|---|
|
Duration of Response
|
4.4 months
Interval 4.2 to 33.7
|
SECONDARY outcome
Timeframe: baseline until documented tumor progression (up to 5 years)Population: All enrolled participants who experienced disease progression.
The period from study entry until disease progression, death or date of last contact.
Outcome measures
| Measure |
Pemetrexed
n=7 Participants
Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
|
|---|---|
|
Progression-Free Survival
|
3.1 months
Interval 0.9 to 23.7
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Pemetrexed
n=27 Participants
Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
|
|---|---|
|
Overall Survival
|
7.4 months
Interval 1.4 to 23.7
|
Adverse Events
Pemetrexed
Serious events: 5 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed
Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.7%
1/27 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.7%
1/27 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
Pyelonephritis
|
3.7%
1/27 • Number of events 1
|
|
Investigations
Blood alkaline phosphatase increased
|
3.7%
1/27 • Number of events 1
|
|
Investigations
Haemoglobin decreased
|
3.7%
1/27 • Number of events 1
|
|
Investigations
White blood cell count decreased
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.7%
1/27 • Number of events 1
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
3.7%
1/27 • Number of events 1
|
Other adverse events
| Measure |
Pemetrexed
Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
85.2%
23/27
|
|
Blood and lymphatic system disorders
Leukopenia
|
70.4%
19/27
|
|
Blood and lymphatic system disorders
Lymphatics
|
14.8%
4/27
|
|
Blood and lymphatic system disorders
Neutropenia
|
63.0%
17/27
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
37.0%
10/27
|
|
Cardiac disorders
Cardiovascular
|
7.4%
2/27
|
|
Ear and labyrinth disorders
Auditory
|
7.4%
2/27
|
|
Eye disorders
Ocular
|
14.8%
4/27
|
|
Gastrointestinal disorders
Gastrointestinal
|
59.3%
16/27
|
|
Gastrointestinal disorders
Nausea/vomiting
|
48.1%
13/27
|
|
General disorders
Constitutional
|
77.8%
21/27
|
|
General disorders
Pain
|
44.4%
12/27
|
|
Hepatobiliary disorders
Hepatic
|
18.5%
5/27
|
|
Infections and infestations
Infection
|
44.4%
12/27
|
|
Investigations
Alkaline phosphatase
|
40.7%
11/27
|
|
Investigations
Serum glutamic oxaloacetic transaminase
|
14.8%
4/27
|
|
Metabolism and nutrition disorders
Metabolic
|
74.1%
20/27
|
|
Nervous system disorders
Neurotoxicity
|
29.6%
8/27
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
11.1%
3/27
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.8%
4/27
|
|
Skin and subcutaneous tissue disorders
Dermatologic
|
40.7%
11/27
|
|
Vascular disorders
Hemorrhage
|
7.4%
2/27
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60