Irinotecan Combined With Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer : a Single Center Prospective Clinical Trial

Peking University

Status and phase: Unknown; Phase 2

Conditions: Advanced Esophageal Squamous Carcinoma

Treatments: Drug: irinotecan/cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01051765

IP-AEC1

Details and patient eligibility

About

Irinotecan, as one new agent used in advanced esophageal carcinoma, has been shown to be effective and safe in western studies. Different with westerns, squamous carcinoma is the main pathological type in china patients. The investigators then initiated a prospective phase II clinical trial with irinotecan/cisplatin as the 1st line treatment in advanced esophageal carcinoma to observe the efficacy and safety of the combination.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having signed informed consent
• Age 18 to 70 years old
• Histologically confirmed esophageal squamous carcinoma, no prior palliative chemotherapy; recurrence from last adjuvant chemotherapy or adjuvant radiotherapy should be longer than 6 months; no prior treatment of irinotecan as adjuvant chemotherapy, total dose of cisplatin is less than 300mg/m2 if used in adjuvant chemotherapy
• Unresectable recurrent or metastatic disease
• Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
• Karnofsky performance status ≥70
• Life expectancy of ≥3 month
• No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
• ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
• Serum AKP < 2.5 times ULN (within 7 days before enrollment)
• Serum creatinine <1.0 times ULN (within 7 days before enrollment)
• Bilirubin level < 1.0 times ULN (within 7 days before enrollment)
• WBC>4,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl(within 7 days before enrollment)
• No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever>38℃；
• Good compliance

Exclusion criteria

• previous treatment of palliative chemotherapy or recurrence less than 6 months from time of last adjuvant chemo-/radiotherapy
• Known hypersensitivity to irinotecan
• Only with Brain or bone metastasis
• Tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung
• No measurable lesions, eg. pleural fluid and ascites
• Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
• Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months or
• Pregnancy or lactation period
• Other previous malignancy within 5 year, except non-melanoma skin cancer
• Chronic diarrhea
• Mentally abnormal or disable cognition,including CNS metastasis

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

irinotecan/cisplatin

Experimental group

Description:

irinotecan 130mg/m2 d1 cisplatin: 30mg/m2, d1,d2 every three weeks

Treatment:

Drug: irinotecan/cisplatin