Gastric CancerPhase 2NCT00980603
Docetaxel Versus Docetaxel Plus Cisplatin Versus Docetaxel Plus S-1 as Second-line Chemotherapy in Metastatic Gastric Cancer
A Phase 2 study testing docetaxel, docetaxel, cisplatin and docetaxel, S-1 in people with Gastric Cancer, run by National Cancer Center, Korea at 4 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- docetaxel, docetaxel, cisplatin and docetaxel, S-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Nov 2008to May 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites, 4 recruiting
- Recruiting
Research Institute and Hospital, National Cancer Center Korea
Goyang, 410-769
Sook Ryun Park, M.D., 82-31-920-1609 ext. 1609, sukryun73@hanmail.net
Young Lan Park, RN, 82-31-920-0422 ext. 0422, lan0729@hanmail.net
- Not yet recruiting
Gachon University Gil Hospital
Inchon, 405-760
Dong Bok Shin, M.D., Ph.D., dbs@gilhospital.com
Dong Bok Shin, M.D., Ph.D.
- Recruiting
Chungbuk National University Hospital
Jeonju, 361-711
Hye-Suk Han, M.D., sook3529@hanmail.net
Hye-Suk Han, M.D.
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 463-707
Keun-Wook Lee, M.D., Ph.D., hmodoctor@hanmail.net
Keun-Wook Lee, M.D., Ph.D.
About this study
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
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
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- docetaxel, docetaxel, cisplatin, docetaxel, S-1
- Keywords
- gastric cancer, metastatic, docetaxel, cisplatin, S-1
- Medical subject headings
- Stomach Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
docetaxel 75 mg/m2, IV on day 1 of each 3 week cycle until progression or unacceptable toxicity develops
docetaxel, cisplatinDrug
docetaxel 60 mg/m2 and cisplatin 60 mg/m2, IV on day 1 of each 3 week cycle until progression or unacceptable toxicity develops
docetaxel, S-1Drug
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
| Study group | Role | What they receive |
|---|---|---|
| docetaxel | Active comparator | Not described Receives: Drug: docetaxel |
| doctaxel plus cisplatin | Experimental | Not described Receives: Drug: docetaxel, cisplatin |
| docetaxel plus S-1 | Experimental | Not described Receives: Drug: docetaxel, S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Measured: every 2 cycles
Secondary outcomes (1)
time to progression
Measured: every 2 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startNov 2008
- Primary completionNov 2010 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Seoul National University Bundang Hospital, Chungbuk National University Hospital, Gachon University Gil Medical Center
- Investigators
- Sook Ryun Park, Dr., Principal investigator, Research Institute and Hospital, National Cancer Center Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980603
- Sponsor's protocol ID
- NCCCTS-07-296
- Status last verified
- Sep 2009
- First submitted
- 18 Sep 2009
- Last updated
- 21 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00980603
- Acronym / sponsor ID
- NCCCTS-07-296
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, metastatic, docetaxel, cisplatin, S-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Seoul National University Bundang Hospital, Chungbuk National University Hospital, Gachon University Gil Medical Center
- Study start
- Nov 2008
- Primary completion
- Nov 2010 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 21 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| docetaxel | Active comparator | Drug: docetaxel |
| doctaxel plus cisplatin | Experimental | Drug: docetaxel, cisplatin |
| docetaxel plus S-1 | Experimental | Drug: docetaxel, S-1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docetaxeldocetaxel 75 mg/m2, IV on day 1 of each 3 week cycle until progression or unacceptable toxicity develops | Drug | docetaxel |
| docetaxel, cisplatindocetaxel 60 mg/m2 and cisplatin 60 mg/m2, IV on day 1 of each 3 week cycle until progression or unacceptable toxicity develops | Drug | doctaxel plus cisplatin |
| docetaxel, S-1docetaxel 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 | Drug | docetaxel plus S-1 |
Primary outcome
response rate
Time frame: every 2 cycles
1 secondary outcome
time to progression
Time frame: every 2 cycles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sook Ryun Park, Dr. principal investigator
Research Institute and Hospital, National Cancer Center Korea
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel, docetaxel, cisplatin and docetaxel, S-1 in people with Gastric Cancer, run by National Cancer Center, Korea at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sook Ryun Park, Dr. (82-31-920-1609 ext. 1609, sukryun73@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: every 2 cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2009.