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

Primary Purpose

Gastric Cancer

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

docetaxel

docetaxel, cisplatin

docetaxel, S-1

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, metastatic, docetaxel, cisplatin, S-1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Chungbuk National University HospitalRecruiting
Research Institute and Hospital, National Cancer Center KoreaRecruiting
Gachon University Gil Hospital
Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

docetaxel

doctaxel plus cisplatin

docetaxel plus S-1

Arm Description

Outcomes

Primary Outcome Measures

response rate

Secondary Outcome Measures

time to progression

Full Information

NCT ID

NCT00980603

First Posted

September 18, 2009

Last Updated

September 18, 2009

Sponsor

National Cancer Center, Korea

Collaborators

Seoul National University Bundang Hospital, Chungbuk National University Hospital, Gachon University Gil Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00980603

Brief Title

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

Official Title

A Randomized Phase II Study of Docetaxel vs. Docetaxel Plus Cisplatin vs. Docetaxel Plus S-1 as Second-line Chemotherapy After Cisplatin Plus S-1 or Capecitabine in Metastatic Gastric Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Unknown status

Study Start Date

November 2008 (undefined)

Primary Completion Date

November 2010 (Anticipated)

Study Completion Date

May 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

National Cancer Center, Korea

Collaborators

Seoul National University Bundang Hospital, Chungbuk National University Hospital, Gachon University Gil Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

To date, the most commonly used first-line chemotherapies have been based on fluorouracil and/or cisplatin in patients with metastatic gastric cancer. Unfortunately, considerable proportions of patients with metastatic gastric cancer do not respond to first-line chemotherapy and most of the patients who do respond eventually experience disease progression. In the second-line treatment, however, standard therapies are less clearly defined. Meanwhile, regarding re-challenge of previous failed drugs as a combination with an other newly introduced chemotherapeutic agent, there are few data. Increased expression and activity of thymidylate synthase, which is inhibited by fluoropyrimidine, is regarded to be the main reason for the development of clinical resistance to fluoropyrimidine. Since the cotreatment of docetaxel and 5-fluorouracil decreases the activity and expression of thymidylate synthase and dihydropyrimidine dehydrogenase (5-fluorouracil degradation enzyme), and increases the expression of orotate phosphoribosyl transferase, the addition of docetaxel into S-1 may recover the sensitivity to S-1 in patients previously resistant to S-1. Several reports found that MDR-1 and MRP-1 are related to cisplatin-resistance; cisplatin induces the overexpression of MRP-1, which reduces intracellular cisplatin accumulation. Since docetaxel suppresses the cisplatin-induced MRP-1 upregulation, the addition of docetaxel into cisplatin may recover the sensitivity to cisplatin in patients previously resistant to cisplatin. Based on these synergism mechanisms, we speculate that the cotreatment of docetaxel and cisplatin or S-1 has better anti-tumor activity than docetaxel alone in patients resistant to cisplatin or S-1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

docetaxel

Arm Type

Active Comparator

Arm Title

doctaxel plus cisplatin

Arm Type

Experimental

Arm Title

docetaxel plus S-1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

docetaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

docetaxel, cisplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

docetaxel, S-1

Intervention Description

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

Primary Outcome Measure Information:

Title

response rate

Time Frame

every 2 cycles

Secondary Outcome Measure Information:

Title

time to progression

Time Frame

every 2 cycles

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sook Ryun Park, Dr.

Phone

82-31-920-1609

Ext

1609

sukryun73@hanmail.net

First Name & Middle Initial & Last Name or Official Title & Degree

Young Lan Park, CRC

Phone

82-31-920-0422

Ext

0422

lan0729@hanmail.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sook Ryun Park, Dr.

Organizational Affiliation

Research Institute and Hospital, National Cancer Center Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chungbuk National University Hospital

City

Chonju

ZIP/Postal Code

361-711

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hye-Suk Han, M.D.

sook3529@hanmail.net

First Name & Middle Initial & Last Name & Degree

Hye-Suk Han, M.D.

Facility Name

Research Institute and Hospital, National Cancer Center Korea

City

Goyang

ZIP/Postal Code

410-769

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sook Ryun Park, M.D.

Phone

82-31-920-1609

Ext

1609

sukryun73@hanmail.net

First Name & Middle Initial & Last Name & Degree

Young Lan Park, RN

Phone

82-31-920-0422

Ext

0422

lan0729@hanmail.net

First Name & Middle Initial & Last Name & Degree

Sook Ryun Park, M.D.

First Name & Middle Initial & Last Name & Degree

Noe Kyeong Kim, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Youngiee Park, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Byung-Ho Nam, Ph.D.

Facility Name

Gachon University Gil Hospital

City

Inchon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dong Bok Shin, M.D., Ph.D.

dbs@gilhospital.com

First Name & Middle Initial & Last Name & Degree

Dong Bok Shin, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Sun Jin Sym, M.D.

Facility Name

Seoul National University Bundang Hospital

City

Seongnam

ZIP/Postal Code

463-707

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Keun-Wook Lee, M.D., Ph.D.

hmodoctor@hanmail.net

First Name & Middle Initial & Last Name & Degree

Keun-Wook Lee, M.D., Ph.D.

12. IPD Sharing Statement

Learn more about this trial

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

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