Weekly Docetaxel/Irinotecan for Non-resectable Gastric Cancers After Cisplatin Plus 5-FU/Leucovorin

NCT ID: NCT00166881

Last Updated: 2013-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-06-30
• Study Completion Date: 2011-06-30

Brief Summary

In this study, the investigators will use P-HDFL, a regimen with high tumor remission rate (~ 60-70%) and with only modest treatment-associated toxicities, as induction chemotherapy for patients with non-resectable gastric cancer. For those patients who have achieved complete response (CR) or partial response (PR), DI will be used to "consolidate" the remission. For those patients who fail to achieve remission by P-HDFL, DI will be used as salvage chemotherapy. The efficacy and toxicities of DI in these two settings will be evaluated in this prospective study.

Detailed Description

1. To evaluate if weekly Docetaxel-Irinotecan,a potentially non-cross-resistant regimen,can prolong the overall survival (OS) or the duration of remission in those patients who have achieved CR or PR by P-HDFL regimen

2. To evaluate the efficacy of weekly Docetaxel-Irinotecan combination as salvage regimen for those patients who have either failed to achieve remission or have recurred from P-HDFL chemotherapy

3. To find out the optimal doses for docetaxel and irinotecan in a weekly dosing schedule for gastric cancer patients

4. To evaluate the toxicities of weekly Docetaxel-Irinotecan regimen in inoperable gastric cancers

Conditions

Gastric Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A, 2, III

Weekly Docetaxel-Irinotecan for Inoperable Gastric Cancers After P-HDFL

Group Type: EXPERIMENTAL

Docetaxel-Irinotecan

Intervention Type: DRUG

Docetaxel-Irinotecan, weekly, days 1, 8, 15, repeated every 4 weeks

Interventions

Docetaxel-Irinotecan

Docetaxel-Irinotecan, weekly, days 1, 8, 15, repeated every 4 weeks

Intervention Type: DRUG

Other Intervention Names

Docetaxel (taxotere); Irinotecan (campto, CPT-11)

Eligibility Criteria

Inclusion Criteria

1. Histologically or cytologically confirmed gastric adenocarcinoma

2. Measurable or evaluable disease

3. No previous C/T

4. Age 16 ~ 75 years

5. Karnofsky Performance Status of 60%

6. 4 weeks after R/T

7. Adjuvant C/T: the last dosing of C/T 6 months before enrollment

8. WBC >= 4,000, platelets >= 100K, Creatinine <= 1.5mg/dl and proteinuria <1+, normal serum bil, transaminase <= 3.5x ULN, TG > 70mg/dl

Exclusion Criteria

1. CNS metastasis

2. Patients receive concomitant anti-cancer C/T or R/T

3. Patients who are pregnant and with an expected life expectancy less than 3 months

4. Symptomatic heart disease, active infection, extensive liver disease, or liver cirrhosis

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Far Eastern Memorial Hospital

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann-Lii Cheng, M.D.,Ph.D.

Role: STUDY_CHAIR

Department of Oncology, National Taiwan University Hospital

Locations

Department of Oncology, National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

57M9

Identifier Type: -

Identifier Source: org_study_id