Phase 2 N=41 Treatment

Irinotecan Study For Cervical Cancer

Uterine Cervical Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT00136955 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Jun 2009

Primary outcome: Primary: Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population) — 8; 7; 11; 6 participant

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Irinotecan (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Pfizer
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)	8; 7; 11; 6; 0; 0	—
PRIMARY Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)	8; 8; 13; 8; 4; 0	—
SECONDARY Overall Survival (OS) and Time to Tumor Progression (TTP) (Evaluable Population)	652; 277	—
SECONDARY Overall Survival (OS) and Time to Tumor Progression (ITT Population)	448; 263	—

Summary

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00136955). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.