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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: All India Institute of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Carcinoma to the Uterine Cervix
• Recurrent Carcinoma Cervix
• Cervix Carcinoma Recurrent

Interventions

Type	Name	Description
DRUG	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
DRUG	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

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-07-08
• Last updated: 2015-07-08

Locations

1 site across 1 country: India