Back to resultsEffectiveness of Chemotherapy in Metastatic or Recurrent Carcinoma Cervix
Primary Purpose
Metastatic Carcinoma to the Uterine Cervix, Recurrent Carcinoma Cervix, Cervix Carcinoma Recurrent
Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Paclitaxel and carboplatin
Paclitaxel and carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Carcinoma to the Uterine Cervix focused on measuring recurrent or metastatic carcinoma cervix chemotherapy
Eligibility Criteria
Inclusion Criteria:
1. Histologically proven case of squamous or adenocarcinoma or adenosquamous carcinoma 2.ECOG performance status 0,1 and 2 3.Adequate hematologic, renal and liver functions 4.Informed consent 5.Measurable disease by CT scan or USG abdomen or MRI
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Exclusion Criteria:
- ECOG performance status 3 or 4
- Impaired blood counts: those patients with an absolute neutrophil count <1,500/μL, platelet counts <100,000/μL, will be ineligible.
- Impaired renal /liver functions as indicated by:
Serum bilirubin >1.5× normal, AST level more than 3× normal, Alkaline phosphatase level more than 3× institutional normal, or a Serum creatinine level more than 1.2 mg/dL. Patients with serum creatinine level of more than 1.2 mg/dL but less than 1.5 mg/dL are eligible if creatinine clearance is 70 ml/min were eligible if a creatinine clearance determination was more than 50 mL/min.
4. H/o prior chemotherapy for metastatic disease, 5. H/O concurrent or past malignancy other than carcinoma cervix, 6. CNS metastasis, or 7. Bilateral hydronephrosis that could not be alleviated by ureteral stents or percutaneous nephrostomy.
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Sites / Locations
- AIIMS
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
pacli carb 3
pacli carb 1
Arm Description
Paclitaxel 175 mg/ m2 administered in 250 ml normal saline over 3 hours and carboplatin AUC 4-5 administered in 250 ml 5%D over 2 hours. Therapy repeated every three weekly
Paclitaxel 60 mg/ m2 administered in 250 ml normal saline over 1 hour and carboplatin AUC 2 administered in 250 ml 5%D over 1 hour. Therapy repeated every weekly
Outcomes
Primary Outcome Measures
Time to progression (length of time from start of chemotherapy to evidence of cancer progression.
Secondary Outcome Measures
Response rate
Overall survival
Quality Of Life Questionnaire
Full Information
NCT ID
NCT02492503
First Posted
January 8, 2014
Last Updated
July 7, 2015
Sponsor
All India Institute of Medical Sciences, New Delhi
1. Study Identification
Unique Protocol Identification Number
NCT02492503
Brief Title
Effectiveness of Chemotherapy in Metastatic or Recurrent Carcinoma Cervix
Official Title
An Open Label Randomized Phase 2, Pilot Study to Investigate the Effectiveness of Palliative Chemotherapy in Stage IVB, Recurrent or Persistent Carcinoma Cervix
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Experience with substituting carboplatin for cisplatin is limited in advanced and recurrent cervix cancer and there has been no counterpart to GOG 158, which documented therapeutic equivalency of cisplatin/paclitaxel and carboplatin/paclitaxel for treatment of ovarian cancer, performed in a cervix cancer population.
Detailed Description
This trial will be a prospective, randomized phase II pilot study. Consecutive patients of metastatic, recurrent or refractory carcinoma cervix enrolled in gynecology clinic at IRCH, AIIMS will be taken into study after taking informed consent. Patients will be randomized into two arms. Each arm shall contain 20 patients. The patients shall receive paclitaxel and carboplatin q3wk in first arm and paclitaxel and carboplatin q1 wk in second arm.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Carcinoma to the Uterine Cervix, Recurrent Carcinoma Cervix, Cervix Carcinoma Recurrent
Keywords
recurrent or metastatic carcinoma cervix chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pacli carb 3
Arm Type
Active Comparator
Arm Description
Paclitaxel 175 mg/ m2 administered in 250 ml normal saline over 3 hours and carboplatin AUC 4-5 administered in 250 ml 5%D over 2 hours. Therapy repeated every three weekly
Arm Title
pacli carb 1
Arm Type
Active Comparator
Arm Description
Paclitaxel 60 mg/ m2 administered in 250 ml normal saline over 1 hour and carboplatin AUC 2 administered in 250 ml 5%D over 1 hour. Therapy repeated every weekly
Intervention Type
Drug
Intervention Name(s)
Paclitaxel and carboplatin
Other Intervention Name(s)
Arm1
Intervention Description
Paclitaxel 60 mg/ m2 administered in 250 ml normal saline over 1 hour, and carboplatin AUC 2 administered in 250 ml 5%D over 1 hour. Therapy repeated every weekly
Intervention Type
Drug
Intervention Name(s)
Paclitaxel and carboplatin
Other Intervention Name(s)
Arm 2
Intervention Description
Paclitaxel 175 mg/ m2 administered in 250 ml normal saline over 3 hours and carboplatin AUC 4-5 administered in 250 ml 5%D over 2 hours. Therapy repeated every three weekly
Primary Outcome Measure Information:
Title
Time to progression (length of time from start of chemotherapy to evidence of cancer progression.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Response rate
Time Frame
6 months
Title
Overall survival
Time Frame
6 months
Title
Quality Of Life Questionnaire
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Histologically proven case of squamous or adenocarcinoma or adenosquamous carcinoma 2.ECOG performance status 0,1 and 2 3.Adequate hematologic, renal and liver functions 4.Informed consent 5.Measurable disease by CT scan or USG abdomen or MRI
-
Exclusion Criteria:
ECOG performance status 3 or 4
Impaired blood counts: those patients with an absolute neutrophil count <1,500/μL, platelet counts <100,000/μL, will be ineligible.
Impaired renal /liver functions as indicated by:
Serum bilirubin >1.5× normal, AST level more than 3× normal, Alkaline phosphatase level more than 3× institutional normal, or a Serum creatinine level more than 1.2 mg/dL. Patients with serum creatinine level of more than 1.2 mg/dL but less than 1.5 mg/dL are eligible if creatinine clearance is 70 ml/min were eligible if a creatinine clearance determination was more than 50 mL/min.
4. H/o prior chemotherapy for metastatic disease, 5. H/O concurrent or past malignancy other than carcinoma cervix, 6. CNS metastasis, or 7. Bilateral hydronephrosis that could not be alleviated by ureteral stents or percutaneous nephrostomy.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
lalit kumar, MD,DM
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Study Chair
Facility Information:
Facility Name
AIIMS
City
New Delhi
ZIP/Postal Code
110029
Country
India
12. IPD Sharing Statement
Links:
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2731017/
Description
Witteveen PO et al
Learn more about this trial
Effectiveness of Chemotherapy in Metastatic or Recurrent Carcinoma Cervix
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