Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix

Lilly

Status and phase: Completed; Phase 3

Conditions: Cancer of Cervix

Treatments: Radiation: Brachytherapy; Drug: Gemcitabine; Radiation: Pelvic radiation; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191100

B9E-MC-JHQS

4015

Details and patient eligibility

About

The purpose of this study is to compare the effectiveness of two methods of treating cancer of the cervix. Half the patients will receive gemcitabine plus cisplatin while undergoing radiation therapy, followed by adjuvant gemcitabine and cisplatin and the other half will receive cisplatin along with radiation therapy without adjuvant therapy.

Enrollment: 515 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosed with cancer of cervix
• tumor that can be measured
• no previous treatment with chemotherapy or radiation for this cancer
• Karnofsky Performance Status Score >=70
• able to give written consent
• willing and able to participate in the study, both during the active treatment and the follow-up period.

Exclusion criteria

• impairment such as hearing loss from prior cisplatin therapy
• damage to nerves such as being unable to distinguish hot and cold to touch
• used other experimental medication in past 30 days
• lab test results are not within the limits required for this study
• pregnancy or breast-feeding or possibility of becoming pregnant during this study and not using an approved method of birth control.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

515 participants in 2 patient groups

1

Experimental group

Description:

Cisplatin, 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Gemcitabine 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks Brachytherapy, 30-35 Gy over 1 week Two week rest period with no chemotherapy or radiation Cisplatin, 50 mg/m2, intravenous (IV), day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles

Treatment:

Drug: Cisplatin

Radiation: Brachytherapy

Drug: Gemcitabine

Radiation: Pelvic radiation

2

Active Comparator group

Description:

Cisplatin, 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks Brachytherapy, 30-35 Gy over 1 week

Treatment:

Drug: Cisplatin

Radiation: Brachytherapy

Radiation: Pelvic radiation