A phase II study of Irinotecan (CPT-11) for Leiomyosarcoma of Uterus

UMIN ID: C000000448

Registered date:13/07/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Leiomyosarcoma of Uterus
• Date of first enrollment: 2006/07/01
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Irinotecan 100 mg/m2 q 4 weeks day 1,8,15 2 courses or more

Outcome(s)

• Primary Outcome: Tumor Response
• Secondary Outcome: Progression- Free Survival,Time to Progression,Toxicity,Overall Survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Female

Exclude criteria

1) Patients with previous CPT-11 chemotherapy.
2) Patients with any history of serious drug reactions or hypersensitivity to CPT-11
3) Patients with massive pleural, cardiac effusion, and/or ascites
4) Patients with symptomatic brain metastasis
5) Patients with active infections
6) Patients with diarrhea (watery stool) five times or more in a day
7) Patients with unstable angina, history of cardiac infarction within 6 months, or arrhythmia that requires medical treatment
8) Patients with intestinal paralysis or illeus
9) Patients with interstitial pneumonia or pulmonary fibrosis
10) Patients with active concomitant malignancy.
* Patients with history of any other malignancy within 5 years are ineligible.
* Patients with carcinoma in situ or intramucosal malignancy that was curable with local therapy are eligible.
11) Patients with uncontrolled diabetes mellitus
12) Patients who are under the treatment with Atzanavir
13) Patients during pregnancy or breast-feeding, or unwilling to the use of contraception
14) Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician

Related Information

• Primary Sponsor: Japanese Gynecologic Oncology Group
• Source(s) of Monetary Support: Japanese Gynecologic Oncology Group