Docetaxel Versus Docetaxel Plus Cisplatin Versus Docetaxel Plus S-1 as Second-line Chemotherapy in Metastatic Gastric Cancer

NCT00980603 | Unknown Phase 2 DMC

• 1 other identifier: NCCCTS-07-296
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to assess efficacy and safety of docetaxel alone, docetaxel plus cisplatin, and docetaxel plus S-1 in patients with metastatic gastric cancer after failing 1st line chemotherapy with cisplatin plus S-1 or capecitabine

Conditions

Gastric Cancer

Keywords

gastric cancer; metastatic; docetaxel; cisplatin; S-1

Outcome Measures

Primary Outcomes (1)

• response rate

  every 2 cycles

Secondary Outcomes (1)

• time to progression

  every 2 cycles

Study Arms (3)

docetaxel

ACTIVE COMPARATOR

Drug: docetaxel

doctaxel plus cisplatin

EXPERIMENTAL

Drug: docetaxel, cisplatin

docetaxel plus S-1

EXPERIMENTAL

Drug: docetaxel, S-1

Interventions

docetaxel DRUG

docetaxel 75 mg/m2, IV on day 1 of each 3 week cycle until progression or unacceptable toxicity develops

docetaxel

docetaxel, cisplatin DRUG

docetaxel 60 mg/m2 and cisplatin 60 mg/m2, IV on day 1 of each 3 week cycle until progression or unacceptable toxicity develops

doctaxel plus cisplatin

docetaxel, S-1 DRUG

docetaxel 60 mg/m2 IV on day 1 and S-1 30 mg/m2 bid PO on days 1-14 of each 3 week cycle until progression or unacceptable toxicity develops

docetaxel plus S-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed gastric adenocarcinoma with metastatic disease
• Age ≥18 years
• Eastern Cooperative Oncology Group performance status 0-2
• At least one measurable lesion as defined by RECIST
• Only one prior chemotherapy containing both S-1 or capecitabine and cisplatin for metastatic gastric cancer with documented progression of disease occurring during chemotherapy or within 6 months of completion of chemotherapy
• Adequate major organ function:
• ANC ≥1,500/mm3, Platelet ≥100,000/mm3, serum bilirubin ≤1.5 x upper limit of normal (ULN), AST/ALT ≤2.5 x ULN (≤5 x ULN if liver metastases are present), creatinine clearance ≥50 ml/min using the calculation formula or 24 hours urine collection
• Patients should sign a written informed consent before study entry

You may not qualify if:

• Prior taxane treatment
• Major surgery or radiotherapy less than 4 weeks prior to entry
• NCI CTCAE (version 3.0) adverse events ≥grade 2 except alopecia, fatigue, and weight loss
• Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome, or inability to take oral medication
• Patients with active gastrointestinal bleeding
• Inadequate cardiovascular function
• Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
• Other malignancy within the past 3 years except adequately treated non-melanomatous skin cancer, carcinoma in situ of the cervix, or in situ of prostate cancer Gleason≤7
• Psychiatric disorder that would preclude compliance
• Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or allopurinol
• Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective method of birth control

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Seoul National University Bundang Hospital: collaborator
• Chungbuk National University Hospital: collaborator
• Gachon University Gil Medical Center: collaborator

Study Sites (4)

Research Institute and Hospital, National Cancer Center Korea

Goyang, 410-769, South Korea

RECRUITING

Gachon University Gil Hospital

Inchon, 405-760, South Korea

NOT YET RECRUITING

Chungbuk National University Hospital

Jeonju, 361-711, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Neoplasm Metastasis

Interventions

Docetaxel; Cisplatin; S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Sook Ryun Park, Dr.

  Research Institute and Hospital, National Cancer Center Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sook Ryun Park, Dr.

CONTACT

82-31-920-1609; sukryun73@hanmail.net

Young Lan Park, CRC

CONTACT

82-31-920-0422; lan0729@hanmail.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: September 21, 2009
• Study Start: November 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: May 1, 2011
• Last Updated: September 21, 2009

Record last verified: 2009-09

Locations

KR (4)