- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02492503
Effectiveness of Chemotherapy in Metastatic or Recurrent Carcinoma Cervix
An Open Label Randomized Phase 2, Pilot Study to Investigate the Effectiveness of Palliative Chemotherapy in Stage IVB, Recurrent or Persistent Carcinoma Cervix
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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New Delhi, India, 110029
- AIIMS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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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Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: pacli carb 3
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
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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
Other Names:
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
Other Names:
|
ACTIVE_COMPARATOR: pacli carb 1
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
|
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
Other Names:
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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Time to progression (length of time from start of chemotherapy to evidence of cancer progression.
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Overall survival
Time Frame: 6 months
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6 months
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Response rate
Time Frame: 6 months
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6 months
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Quality Of Life Questionnaire
Time Frame: 6 months
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6 months
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Collaborators and Investigators
Investigators
- Study Chair: lalit kumar, MD,DM, All India Institute of Medical Sciences, New Delhi
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Carcinoma
- Recurrence
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- CA CX CHEMOTHERAPY
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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