Effectiveness of Chemotherapy in Metastatic or Recurrent Carcinoma Cervix

Phase 1

• Conditions: Metastatic Carcinoma to the Uterine Cervix; Recurrent Carcinoma Cervix; Cervix Carcinoma Recurrent
• Interventions: Drug: Paclitaxel and carboplatin

• Registration Number: NCT02492503
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

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 Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-01-08
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-07
• Last Update Submitted: 2015-07-07
• Study First Posted: 2015-07-08
• Last Update Posted: 2015-07-08
• Primary Completion: 2015-08
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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

1. ECOG performance status 3 or 4
2. Impaired blood counts: those patients with an absolute neutrophil count <1,500/μL, platelet counts <100,000/μL, will be ineligible.
3. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pacli carb 3	Paclitaxel and carboplatin	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
pacli carb 1	Paclitaxel and carboplatin	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

Primary Outcome Measures

Name	Time	Method
Time to progression (length of time from start of chemotherapy to evidence of cancer progression.	6 months

Secondary Outcome Measures

Name	Time	Method
Response rate	6 months
Overall survival	6 months
Quality Of Life Questionnaire	6 months

Trial Locations

Locations (1)

AIIMS; 🇮🇳 New Delhi, India