NCT01405235

Study on Paclitaxel Plus Topotecan in Comparison With Topotecan Plus Cisplatin in Recurrent or Persistent Cervical Carcinoma

A Prospective, Randomized Phase III Study to Compare the Effects of Paclitaxel and Topotecan to Those of Cisplatin and Topotecan for Treatment of Patients With Recurrent and Persistent Cervical Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: Institut fuer Frauengesundheit · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Current planning for studies involving patients with recurrent, persistent, or metastasized cervical cancer must take into consideration that up to 75% of all patients are assumed to have already been treated with cisplatin in conjunction with radiation therapy. It seems questionable to continue to treat patients with cisplatin when cancer has recurred. Thus, it is important to seek alternative active combinations. The studies GOG 169 and 179 demonstrated that a combination of paclitaxel and cisplatin was superior to a cisplatin monotherapy with respect to therapeutic response and progression-free survival, as was a combination of topotecan and cisplatin with respect to therapeutic response, progression-free survival, and total survival. To achieve further improvement in total survival and to answer questions regarding the value of using a platinum-free combination, we propose that a study should be conducted to compare the efficacy of a platinum-free combination of paclitaxel and topotecan to a combination of cisplatin and topotecan.

Detailed description

Design: This will be a prospective, randomized, multicenter, non-blinded phase III A study. Dosages: Arm A Paclitaxel 70 mg/m2/d i.v. on Days 1, 8, and 15 in combination with Topotecan 1.75 mg/m2/d i.v. on Days 1, 8, and 15, q 28 d Arm B Topotecan 0.75 mg/m2/d i.v. on Days 1- 3 in combination with Cisplatin 50 mg/m2 i.v. on Day 1, q 21 d Duration of Therapy: Each patient will participate in the study until a maximum of six cycles have been completed, or until there is evidence of disease progression, or until toxicity prevents further therapy. Patients with continued response or stable disease may continue to participate in the study for an additional 3 cycles beyond the original 6 cycles with consent of the Study Director, but this must be documented in the CRF.

Conditions

• Recurrent, Persistent or Metastasized Cervical Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	Paclitaxel 70 mg/m2/d i.v. on Days 1, 8, and 15 in combination with Topotecan 1.75 mg/m2/d i.v. on Days 1, 8, and 15, q 28 d
DRUG	Cisplatin/Paclitaxel	Topotecan 0.75 mg/m2/d i.v. on Days 1- 3 in combination with Cisplatin 50 mg/m2 i.v. on Day 1, q 21 d

Timeline

• Start date: 2006-09-01
• Primary completion: 2012-06-01
• Completion: 2015-01-01
• First posted: 2011-07-29
• Last updated: 2012-04-12

Locations

1 site across 1 country: Germany