Uterine Cervical Neoplasms
Conditions
Keywords
Weekly Irinotecan(60mg/sqm, D1, 8, 15) in combination with Cisplatin (60mg/sqm, D1), Squamous Cell Carcinoma Of The Uterine Cervix
Brief summary
The purpose of the study is to evaluate the efficacy and safety of Irinotecan plus cisplatin as first-line chemotherapy for advanced or recurrent cervical cancer
Interventions
DRUGIrinotecan
An Open Labeled, Single-Arm, Multicentre Phase II Study To Evaluate The Efficacy And Safety Of Weekly Irinotecan (60mg/sqm, D1, 8, 15) Plus Cisplatin (60mg/sqm, D1) As First-Line Chemotherapy For Advanced Or Recurrent Squamous Cell Carcinoma Of The Uterine Cervix
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically documented, advanced or recurrent squamous cell carcinoma of uterine cervix. Patients may have received concurrent (with radiotherapy) or (neo)adjuvant (before or after local treatment) chemotherapy for primary tumor providing that at least 6 months have passed from the completion of previous therapy and the diagnosis of recurrent disease was documented * Having measurable lesion(s), without previous radiation therapy.
Exclusion criteria
* Patients had ever received primary chemotherapy for cervical cancer other than mentioned previously (in the inclusion criteria). * Patients ever received cisplatin with total dose \> 300 mg/m2 and received radiotherapy or local treatment delivered to the target lesion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population) | At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment) | Tumor response according to RECIST. |
| Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population) | At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment) | Tumor response according to RECIST. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) and Time to Tumor Progression (TTP) (Evaluable Population) | 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. | 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. |
| Overall Survival (OS) and Time to Tumor Progression (ITT Population) | 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. | 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. |
Countries
Taiwan
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 8 |
| Overall Study | Incl. prog. disease, protocol violation | 12 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Irinotecan/Cisplatin |
|---|---|
| Age, Continuous | 55.9 years STANDARD_DEVIATION 9.6 |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 40 / — |
| serious Total, serious adverse events | 25 / — |
Outcome results
Primary
Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)
Tumor response according to RECIST.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Irinotecan/Cisplatin | Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population) | complete response | 8 participant |
| Irinotecan/Cisplatin | Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population) | partial response | 8 participant |
| Irinotecan/Cisplatin | Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population) | stable disease | 13 participant |
| Irinotecan/Cisplatin | Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population) | progressive disease | 8 participant |
| Irinotecan/Cisplatin | Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population) | not evaluable | 4 participant |
| Irinotecan/Cisplatin | Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population) | missing | 0 participant |
| Irinotecan/Cisplatin | Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population) | Response Rate (PR + CR) - naive | 16 participant |
Primary
Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)
Tumor response according to RECIST.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Irinotecan/Cisplatin | Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population) | complete response (CR) | 8 participant |
| Irinotecan/Cisplatin | Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population) | partial response (PR) | 7 participant |
| Irinotecan/Cisplatin | Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population) | stable disease (SD) | 11 participant |
| Irinotecan/Cisplatin | Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population) | progressive disease (PD) | 6 participant |
| Irinotecan/Cisplatin | Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population) | not evaluable | 0 participant |
| Irinotecan/Cisplatin | Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population) | missing | 0 participant |
| Irinotecan/Cisplatin | Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population) | Response Rate (PR + CR) - naive | 15 participant |
| Irinotecan/Cisplatin | Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population) | Response Rate (PR + CR) - corrected | 15 participant |
Secondary
Overall Survival (OS) and Time to Tumor Progression (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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Irinotecan/Cisplatin | Overall Survival (OS) and Time to Tumor Progression (ITT Population) | Overall Survival | 448 days |
| Irinotecan/Cisplatin | Overall Survival (OS) and Time to Tumor Progression (ITT Population) | Time to Tumor Progression | 263 days |
Secondary
Overall Survival (OS) and Time to Tumor Progression (TTP) (Evaluable 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Irinotecan/Cisplatin | Overall Survival (OS) and Time to Tumor Progression (TTP) (Evaluable Population) | Overall Survival | 652 days |
| Irinotecan/Cisplatin | Overall Survival (OS) and Time to Tumor Progression (TTP) (Evaluable Population) | Time to tumor progression | 277 days |