Irinotecan Study For Cervical Cancer

Pfizer

Status and phase: Completed; Phase 2

Conditions: Uterine Cervical Neoplasms

Treatments: Drug: Irinotecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00136955

A5961083

XRP4174/2502

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy and safety of Irinotecan plus cisplatin as first-line chemotherapy for advanced or recurrent cervical cancer

Enrollment: 41 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically documented, advanced or recurrent squamous cell carcinoma of uterine cervix. Patients may have received concurrent (with radiotherapy) or (neo)adjuvant (before or after local treatment) chemotherapy for primary tumor providing that at least 6 months have passed from the completion of previous therapy and the diagnosis of recurrent disease was documented
• Having measurable lesion(s), without previous radiation therapy.

Exclusion criteria

• Patients had ever received primary chemotherapy for cervical cancer other than mentioned previously (in the inclusion criteria).
• Patients ever received cisplatin with total dose > 300 mg/m2 and received radiotherapy or local treatment delivered to the target lesion.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

irinitecan/cisplatin

Experimental group

Description:

experimental arm consists of patients who receive irinotecan/cisplatin

Treatment:

Drug: Irinotecan