Trial Outcomes & Findings for Irinotecan Study For Cervical Cancer (NCT NCT00136955)
NCT ID: NCT00136955
Last Updated: 2015-06-19
Results Overview
Tumor response according to RECIST.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)
Results posted on
2015-06-19
Participant Flow
All 41 subjects had a primary diagnosis of squamous cell carcinoma of the cervix with a mean duration of 2.8 years (range: 0-12.9 years) since first diagnosis. No subject had a history of other cancer.
Participant milestones
| Measure |
Irinotecan/Cisplatin
Intravenous irinotecan (60 milligrams \[mg\]/metered square \[m2\]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
Irinotecan/Cisplatin
Intravenous irinotecan (60 milligrams \[mg\]/metered square \[m2\]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Incl. prog. disease, protocol violation
|
12
|
Baseline Characteristics
Irinotecan Study For Cervical Cancer
Baseline characteristics by cohort
| Measure |
Irinotecan/Cisplatin
n=41 Participants
Intravenous irinotecan (60 milligrams \[mg\]/metered square \[m2\]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
|
|---|---|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)Population: Evaluable population: 1) Patient received at least two complete cycles of treatment (8 weeks on study). If progression occurred before end of second cycle, patient considered evaluable (early progression); 2) all baseline lesions assessed at least once after second cycle with same method of measurement as baseline; 3) no major protocol violation.
Tumor response according to RECIST.
Outcome measures
| Measure |
Irinotecan/Cisplatin
n=32 Participants
Intravenous irinotecan (60 milligrams \[mg\]/metered square \[m2\]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
|
|---|---|
|
Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)
missing
|
0 participant
|
|
Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)
Response Rate (PR + CR) - naive
|
15 participant
|
|
Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)
complete response (CR)
|
8 participant
|
|
Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)
partial response (PR)
|
7 participant
|
|
Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)
stable disease (SD)
|
11 participant
|
|
Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)
progressive disease (PD)
|
6 participant
|
|
Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)
not evaluable
|
0 participant
|
|
Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)
Response Rate (PR + CR) - corrected
|
15 participant
|
PRIMARY outcome
Timeframe: At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)Population: Intent-to-treat (ITT) population: All included subjects who received at least one drop of study medication will be included in the ITT population.
Tumor response according to RECIST.
Outcome measures
| Measure |
Irinotecan/Cisplatin
n=41 Participants
Intravenous irinotecan (60 milligrams \[mg\]/metered square \[m2\]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
|
|---|---|
|
Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)
complete response
|
8 participant
|
|
Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)
partial response
|
8 participant
|
|
Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)
stable disease
|
13 participant
|
|
Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)
progressive disease
|
8 participant
|
|
Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)
not evaluable
|
4 participant
|
|
Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)
missing
|
0 participant
|
|
Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)
Response Rate (PR + CR) - naive
|
16 participant
|
SECONDARY outcome
Timeframe: Tumor response measurements were made at baseline, according to RECIST criteria. After end of treatment, subject was followed-up every 12 weeks plus or minus 2 weeks.Population: Evaluable population: 1) Patient received at least two complete cycles of treatment (8 weeks on study). If progression occurred before end of second cycle, patient considered evaluable (early progression); 2) all baseline lesions assessed at least once after second cycle with same method of measurement as baseline; 3) no major protocol violation.
TTP is date of first infusion to first date of documented progression or date of death due to progressive disease or date of further anti-tumor therapy, whichever occurs first. OS is time from date of first infusion to date of death due to any cause or last date patient is known to be alive at date of data cutoff for final analysis.
Outcome measures
| Measure |
Irinotecan/Cisplatin
n=32 Participants
Intravenous irinotecan (60 milligrams \[mg\]/metered square \[m2\]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
|
|---|---|
|
Overall Survival (OS) and Time to Tumor Progression (TTP) (Evaluable Population)
Overall Survival
|
652 days
Interval 398.0 to 840.0
|
|
Overall Survival (OS) and Time to Tumor Progression (TTP) (Evaluable Population)
Time to tumor progression
|
277 days
Interval 157.0 to 682.0
|
SECONDARY outcome
Timeframe: Tumor response measurements were made at baseline, according to RECIST criteria. After end of treatment, subject was followed-up every 12 weeks plus or minus 2 weeks.Population: Intent-to-treat (ITT) population: All included subjects who received at least one drop of study medication will be included in the ITT population.
TTP is date of first infusion to first date of documented progression or date of death due to progressive disease or date of further anti-tumor therapy, whichever occurs first. OS is time from date of first infusion to date of death due to any cause or last date patient is known to be alive at date of data cutoff for final analysis.
Outcome measures
| Measure |
Irinotecan/Cisplatin
n=41 Participants
Intravenous irinotecan (60 milligrams \[mg\]/metered square \[m2\]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
|
|---|---|
|
Overall Survival (OS) and Time to Tumor Progression (ITT Population)
Overall Survival
|
448 days
Interval 348.0 to 680.0
|
|
Overall Survival (OS) and Time to Tumor Progression (ITT Population)
Time to Tumor Progression
|
263 days
Interval 157.0 to 652.0
|
Adverse Events
Irinotecan/Cisplatin
Serious events: 25 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Irinotecan/Cisplatin
Intravenous irinotecan (60 milligrams \[mg\]/metered square \[m2\]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.3%
3/41
|
|
Blood and lymphatic system disorders
Leukopenia
|
34.1%
14/41
|
|
Gastrointestinal disorders
Diarrhoea
|
14.6%
6/41
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
2.4%
1/41
|
|
Gastrointestinal disorders
Ileus
|
2.4%
1/41
|
|
Gastrointestinal disorders
Nausea
|
12.2%
5/41
|
|
Gastrointestinal disorders
Proctitis
|
2.4%
1/41
|
|
Gastrointestinal disorders
Vomiting
|
12.2%
5/41
|
|
General disorders
Asthenia
|
9.8%
4/41
|
|
General disorders
Pyrexia
|
19.5%
8/41
|
|
Infections and infestations
Infection
|
24.4%
10/41
|
|
Investigations
Haemoglobin
|
22.0%
9/41
|
|
Investigations
Neutrophil count decreased
|
31.7%
13/41
|
|
Investigations
Platelet count
|
9.8%
4/41
|
|
Investigations
Weight decreased
|
2.4%
1/41
|
|
Metabolism and nutrition disorders
Anorexia
|
4.9%
2/41
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.4%
1/41
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.4%
1/41
|
|
Nervous system disorders
Depressed level of consciousness
|
2.4%
1/41
|
|
Nervous system disorders
Syncope
|
2.4%
1/41
|
|
Renal and urinary disorders
Bladder pain
|
2.4%
1/41
|
|
Renal and urinary disorders
Urinary retention
|
2.4%
1/41
|
|
Renal and urinary disorders
Urogenital disorder
|
2.4%
1/41
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/41
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.4%
1/41
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
1/41
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.4%
1/41
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
2.4%
1/41
|
|
Vascular disorders
Hypotension
|
4.9%
2/41
|
Other adverse events
| Measure |
Irinotecan/Cisplatin
Intravenous irinotecan (60 milligrams \[mg\]/metered square \[m2\]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
22.0%
9/41
|
|
Blood and lymphatic system disorders
Leukopenia
|
58.5%
24/41
|
|
Gastrointestinal disorders
Abdominal pain
|
14.6%
6/41
|
|
Gastrointestinal disorders
Constipation
|
17.1%
7/41
|
|
Gastrointestinal disorders
Diarrhoea
|
63.4%
26/41
|
|
Gastrointestinal disorders
Flatulence
|
7.3%
3/41
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
7.3%
3/41
|
|
Gastrointestinal disorders
Nausea
|
48.8%
20/41
|
|
Gastrointestinal disorders
Vomiting
|
65.9%
27/41
|
|
General disorders
Asthenia
|
24.4%
10/41
|
|
General disorders
Oedema
|
7.3%
3/41
|
|
General disorders
Pain
|
24.4%
10/41
|
|
General disorders
Pyrexia
|
7.3%
3/41
|
|
Infections and infestations
Infection
|
26.8%
11/41
|
|
Investigations
Alanine aminotransferase increased
|
7.3%
3/41
|
|
Investigations
Aspartate aminotransferase increased
|
9.8%
4/41
|
|
Investigations
Haemoglobin
|
78.0%
32/41
|
|
Investigations
Neutrophil count decreased
|
39.0%
16/41
|
|
Investigations
Platelet count
|
36.6%
15/41
|
|
Investigations
Weight decreased
|
12.2%
5/41
|
|
Metabolism and nutrition disorders
Anorexia
|
24.4%
10/41
|
|
Nervous system disorders
Dizziness
|
9.8%
4/41
|
|
Nervous system disorders
Headache
|
7.3%
3/41
|
|
Psychiatric disorders
Insomnia
|
24.4%
10/41
|
|
Renal and urinary disorders
Micturition disorder
|
7.3%
3/41
|
|
Renal and urinary disorders
Renal failure
|
9.8%
4/41
|
|
Renal and urinary disorders
Urinary retention
|
7.3%
3/41
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
9.8%
4/41
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.4%
10/41
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
24.4%
10/41
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
9.8%
4/41
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.3%
3/41
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
7.3%
3/41
|
|
Surgical and medical procedures
Packed red blood cell transfusion
|
12.2%
5/41
|
|
Vascular disorders
Hypertension
|
9.8%
4/41
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER