Phase I/II Study of Paclitaxel Plus CPT-11 in Pts. With 2nd Line Chemotherapy of Inoperable or Recurrent GC.

NCT00209612 | Withdrawn Phase 1 DMC

• 2 other identifiers: HGCSG0402PacIri
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using CPT-11 and Paclitaxel in pre-treated patients with metastatic gastric cancer. The usefulness of the this regimen is evaluated by response rate, median survival time, and progression free survival.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting. Determine the clinical response rate with Recommended dose in Phase II setting.

  1-year

Secondary Outcomes (2)

• Determine the clinical response rate of patients in Phase I setting.

  1-year

• Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting.

  2-years

Study Arms (1)

1

EXPERIMENTAL

Paclitaxel+Irinotecan

Drug: Taxol; Drug: Campt, Topotesin

Interventions

Taxol DRUG

Day1,15 X mg/m2, IV (in the vein)

Also known as: Paclitaxel

1

Campt, Topotesin DRUG

Day1,15 Y mg/m2, IV (in the vein)

Also known as: irinotecan

1

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed metastatic or recurrent gastric cancer with prior treatment for advanced disease.
• Patients who have received 1cycle cancer therapy (radiotherapy, chemotherapy or chemoradiotherapy) given \> 4 weeks prior to the beginning of study therapy
• At least one measurable lesion according to the RECIST criteria. Minimum indicator lesion size: \> 10 mm measured by spiral CT or \>20mm measured by conventional techniques(Except for Phase I setting).
• Patients aged between 20 and 75 years, inclusive, at the time of acquisition of informed consent
• Patients with performance status(ECOG) 0 to 2
• Abnormal hematologic values (WBC ≥ 3.5 x 109/L, Hemoglobin ≥ 9.0g/dl, platelet count ≥ 100 x 109/L)
• Serum cleatinine ≤ 1.5mg/dl
• Serum bilirubin ≤ 1.5mg/dl. ALT, AST ≤ 2.0 x upper normal limit (or ≤ 3 x upper normal limit in the case of liver metastases)
• Normal ECG
• Life expectancy ≥ 3 months
• Patients who have given written informed consent to participate in this study

You may not qualify if:

• Patients with active multiple cancers; or even if the multiple cancers are metachronous, have a disease-free period of less than 5 years (but excluding cancer in situ and skin cancer) (Except for Phase I setting)
• Serious, uncontrolled, concurrent infection(s) or illness(es)
• Patients with no serious concurrent complications (such as heart disease, Intestinal pneumonia)
• Patients with Liver cirrhosis
• Patients with fresh hemorrhage from the gastrointestinal tract
• Patients with poorly controlled diabetes or are treated by continuous use of insulin
• Patients with concurrent psychiatric disease or psychotic symptoms, and judged to have difficulties participating in the study
• Patients with retention of body fluid(pleural effusion, ascites, pericardial effusion) necessitating treatment
• Patients with diarrhea (watery stool)
• Patients with infection, intestinal palsy or intestinal occlusion
• Patients with brain metastasis
• Patients with Gilbert syndrome
• Patients who have experienced serious drug allergy in the past
• Patients who are pregnant and lactating or hope to become pregnant during the study period
• Patients with prior Taxan (Paclitaxel, Docetaxel) or CPT-11 treatment

Sponsors & Collaborators

• Hokkaido Gastrointestinal Cancer Study Group: lead
• Hokkaido University Hospital: collaborator

Study Sites (1)

・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)

Sapporo, Hokkaido, 060-8638, Japan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Paclitaxel; Irinotecan

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Masahiro Asaka, MD, PhD

  Hokkaido Gastrointestinal Cancer Study Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: April 1, 2004
• Primary Completion: November 1, 2008
• Study Completion: March 1, 2009
• Last Updated: February 17, 2009

Record last verified: 2009-02

Locations

JP (1)