An Open Label Randomized Phase 2, Pilot Study to Investigate the Effectiveness of Palliative Chemotherapy in Stage IVB, Recurrent or Persistent Carcinoma Cervix
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Time to progression (length of time from start of chemotherapy to evidence of cancer progression.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •H/o prior chemotherapy for metastatic disease,
- •H/O concurrent or past malignancy other than carcinoma cervix,
- •CNS metastasis, or
- •Bilateral hydronephrosis that could not be alleviated by ureteral stents or percutaneous nephrostomy.
Arms & Interventions
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
Intervention: Paclitaxel and carboplatin (Drug)
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
Intervention: Paclitaxel and carboplatin (Drug)
Outcomes
Primary Outcomes
Time to progression (length of time from start of chemotherapy to evidence of cancer progression.
Time Frame: 6 months
Secondary Outcomes
- Response rate(6 months)
- Overall survival(6 months)
- Quality Of Life Questionnaire(6 months)
Investigators
Harish P
senior resident
All India Institute of Medical Sciences, New Delhi