Ovarian NeoplasmsPhase 2NCT00919984
Efficacy Study of Additional Intraperitoneal Chemotherapy to Treat Ovarian Cancer
A Phase 2 study testing IP chemotherapy in people with Ovarian Neoplasms, run by Korea Cancer Center Hospital at 1 site in South Korea.
Trial summary
Most patients with advanced ovarian cancer suffered recurrences. Therefore, adjuvant therapy is recommended for all patients with advanced ovarian cancer. Traditionally, intravenous paclitaxel + carboplatin has been the standard adjuvant therapy. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- IP chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2007to Oct 2010
- 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 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=20 and <=75
- Histologically confirmed epithelial ovarian cancer, primary peritoneal carcinoma, tubal cancer
- Stage 3 or 4
- WBC >= 3500/mm3, ANC >= 1500/mm3, platelet >= 100000/mm3, hemoglobin >= 10 g/dl
- Serum creatinine <= upper normal limit * 1.25
- Total bilirubin <= 1.5mg/mm3, ALT/AST <= upper normal limit * 3, ALP <= upper normal limit * 3
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- Adequate compliance and geographical closeness which make adequate follow-up possible
- GOG performance status 0-2
- Anticipated survival >= 3 months
- Who agreed to participate in this study and signed on informed consent form
Who cannot join
- History of chemotherapy or radiotherapy on abdomen/pelvis area
- Pleural/pericardial effusion, ascites causing respiratory difficulties >= NCI-CTCAE grade 2
- History of other cancers within 5 years
- History of unapproved therapy within 30 days before enrollment
- Other serious diseases which could threat the safety of participants or impair the ability of participants to complete the participation.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea Cancer Center Hospital, Korea Institute of Radiological & Medical Sciences
Seoul, 139-706
About this study
Official title: Phase II Clinical Trial of Intravenous Paclitaxel and Carboplatin Plus Intraperitoneal Paclitaxel as an Adjuvant Chemotherapy in Patients With Optimally Debulked Advanced Epithelial Ovarian Carcinoma
Most patients with advanced ovarian cancer suffered recurrences. Therefore, adjuvant therapy is recommended for all patients with advanced ovarian cancer.
Traditionally, intravenous paclitaxel + carboplatin has been the standard adjuvant therapy.
Recently, intraperitoneal combination chemotherapy has been reported to be effective in ovarian cancer.
We attempted to evaluate the efficacy and feasibility of standard intravenous paclitaxel + carboplatin plus intraperitoneal paclitaxel chemotherapy.
Read the detailed description
Epithelial ovarian cancer is the leading cause of death from gynecologic malignancies worldwide. The recommended treatment includes primary surgery for diagnosis, staging, and cytoreduction, followed by chemotherapy. Epithelial ovarian cancer is more sensitive to cytotoxic drugs than other solid tumors, most patients with advanced ovarian cancer are recommended treatment with postoperative adjuvant chemotherapy. The recommended initial chemotherapy is generally platinum and taxane combination given by intravenous infusion every 3 weeks for 6 courses. This treatment resulted in complete remission in about 50% of ovarian cancer patients and pathologic complete response in 25~30% of patients.
However most patients with advanced ovarian cancer suffered recurrences after primary treatment, median progression free survival is 15.5-22months, and median overall survival is about 31-44months.
As residual ovarian cancer after surgery and initial recurrences are primarily confined to the abdomen, intraperitoneal administration of chemotherapy was proposed several decades ago. In 2006, Armstrong, et al., reported improvement of overall survival in ovarian cancer patient with optimal surgical debulking followed intraperitoneal paclitaxel + cisplatin chemotherapy. The National Cancer Institute (NCI) of the United States recommended to consider intraperitoneal chemotherapy in optimally debulking patients.
In Korea, however, there are few studies about postoperative adjuvant intraperitoneal chemotherapy in optimally debulked (residual mass <1cm) advanced ovarian cancer patients.
Therefore the investigators tend to evaluate the efficacy and feasibility of postoperative adjuvant intraperitoneal chemotherapy. (standard intravenous paclitaxel+carboplatin plus intraperitoneal paclitaxel chemotherapy)
- Conditions
- Ovarian Neoplasms
- Being tested
- IP chemotherapy
- Keywords
- OVARIAN NEOPLASMS, ADJUVANT CHEMOTHERAPY, INTRAPERITONEAL CHEMOTHERAPY
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IP chemotherapyDrug
Also called Paclitaxel, Carboplatin
IV Paclitaxel 175mg/m2 + IV Carboplatin (AUC4.5) AT DAY 1; IP Paclitaxel 60 mg/m2 at day 8; every 21 days, 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| IP Chemotherapy | Experimental | Patients with optimally debulked advanced (stage 3 or 4) epithelial ovarian cancer; IV Paclitaxel 175mg/m2 + IV Carboplatin (AUC4.5) AT DAY 1; IP Paclitaxel 60 mg/m2 at day 8; every 21 days, 6 cycles Receives: Drug: IP chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 year progression-free survival rate.
The time from randomization to the time of disease progression as determined by the investigator or death from any cause.
Progression is diagnosed by imaging or serial tumor marker elevation.
Measured: 2 Year after initial surgery
Secondary outcomes (3)
Median overall survival
Median observed length of life from entry into the study to death; or for living patients, the date of last contact regardless of whether or not this contact is on a subsequent protocol
Measured: From entry into the study to 5 year after treatment or until half of participants are dead
5 year progression-free survival rate
The time from randomization to the time of disease progression as determined by the investigator (by clinical, radiological or pathological means) or death from any cause
Measured: 5 year after initial surgery
5 year overall survival rate
Observed length of life from entry into the study to death; or for living patients, the date of last contact regardless of whether or not this contact is on a subsequent protocol.
Measured: 5 year after initial surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startMay 2007
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: This study stopped due to slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Cancer Center Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang-Young Ryu, Korea Cancer Center Hospital
- Investigators
- SANG YOUNG RYU, M.D., Principal investigator, KOREA CANCER CENTER HOSPITAL, KOREA INSTITUTE OF RADIOLOGICAL & MEDICAL SCIENCES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919984
- Sponsor's protocol ID
- KCCH GY 3001
- Status last verified
- May 2014
- First submitted
- 7 Jun 2009
- Last updated
- 9 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Intravenous Paclitaxel and Carboplatin Plus Intraperitoneal Paclitaxel as an Adjuvant Chemotherapy in Patients With Optimally Debulked Advanced Epithelial Ovarian Carcinoma
- ClinicalTrials.gov ID
- NCT00919984
- Acronym / sponsor ID
- KCCH GY 3001
- Conditions
- Ovarian Neoplasms
- Keywords
- OVARIAN NEOPLASMS, ADJUVANT CHEMOTHERAPY, INTRAPERITONEAL CHEMOTHERAPY
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study stopped due to slow accrual.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Korea Cancer Center HospitalUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 12 Jun 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.
Most patients with advanced ovarian cancer suffered recurrences. Therefore, adjuvant therapy is recommended for all patients with advanced ovarian cancer.
Traditionally, intravenous paclitaxel + carboplatin has been the standard adjuvant therapy.
Recently, intraperitoneal combination chemotherapy has been reported to be effective in ovarian cancer.
We attempted to evaluate the efficacy and feasibility of standard intravenous paclitaxel + carboplatin plus intraperitoneal paclitaxel chemotherapy.
Detailed description
Epithelial ovarian cancer is the leading cause of death from gynecologic malignancies worldwide. The recommended treatment includes primary surgery for diagnosis, staging, and cytoreduction, followed by chemotherapy. Epithelial ovarian cancer is more sensitive to cytotoxic drugs than other solid tumors, most patients with advanced ovarian cancer are recommended treatment with postoperative adjuvant chemotherapy. The recommended initial chemotherapy is generally platinum and taxane combination given by intravenous infusion every 3 weeks for 6 courses. This treatment resulted in complete remission in about 50% of ovarian cancer patients and pathologic complete response in 25~30% of patients.
However most patients with advanced ovarian cancer suffered recurrences after primary treatment, median progression free survival is 15.5-22months, and median overall survival is about 31-44months.
As residual ovarian cancer after surgery and initial recurrences are primarily confined to the abdomen, intraperitoneal administration of chemotherapy was proposed several decades ago. In 2006, Armstrong, et al., reported improvement of overall survival in ovarian cancer patient with optimal surgical debulking followed intraperitoneal paclitaxel + cisplatin chemotherapy. The National Cancer Institute (NCI) of the United States recommended to consider intraperitoneal chemotherapy in optimally debulking patients.
In Korea, however, there are few studies about postoperative adjuvant intraperitoneal chemotherapy in optimally debulked (residual mass <1cm) advanced ovarian cancer patients.
Therefore the investigators tend to evaluate the efficacy and feasibility of postoperative adjuvant intraperitoneal chemotherapy. (standard intravenous paclitaxel+carboplatin plus intraperitoneal paclitaxel chemotherapy)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IP Chemotherapy | Experimental | Drug: IP chemotherapyPatients with optimally debulked advanced (stage 3 or 4) epithelial ovarian cancer; IV Paclitaxel 175mg/m2 + IV Carboplatin (AUC4.5) AT DAY 1; IP Paclitaxel 60 mg/m2 at day 8; every 21 days, 6 cycles |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age >=20 and <=75
- Histologically confirmed epithelial ovarian cancer, primary peritoneal carcinoma, tubal cancer
- Stage 3 or 4
- WBC >= 3500/mm3, ANC >= 1500/mm3, platelet >= 100000/mm3, hemoglobin >= 10 g/dl
- Serum creatinine <= upper normal limit * 1.25
Key exclusion criteria (5 listed)
- History of chemotherapy or radiotherapy on abdomen/pelvis area
- Pleural/pericardial effusion, ascites causing respiratory difficulties >= NCI-CTCAE grade 2
- History of other cancers within 5 years
- History of unapproved therapy within 30 days before enrollment
- Other serious diseases which could threat the safety of participants or impair the ability of participants to complete the participation.
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 |
|---|---|---|
| IP chemotherapyAlso: Paclitaxel, CarboplatinIV Paclitaxel 175mg/m2 + IV Carboplatin (AUC4.5) AT DAY 1; IP Paclitaxel 60 mg/m2 at day 8; every 21 days, 6 cycles | Drug | IP Chemotherapy |
Primary outcome
2 year progression-free survival rate.
Time frame: 2 Year after initial surgery
The time from randomization to the time of disease progression as determined by the investigator or death from any cause. Progression is diagnosed by imaging or serial tumor marker elevation.
3 secondary outcomes
Median overall survival
Time frame: From entry into the study to 5 year after treatment or until half of participants are dead
5 year progression-free survival rate
Time frame: 5 year after initial surgery
5 year overall survival rate
Time frame: 5 year after initial surgery
Results and safety
The study was stopped early (reason given: This study stopped due to slow accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
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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.
SANG YOUNG RYU, M.D. principal investigator
KOREA CANCER CENTER HOSPITAL, KOREA INSTITUTE OF RADIOLOGICAL & MEDICAL SCIENCES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IP chemotherapy in people with Ovarian Neoplasms, run by Korea Cancer Center Hospital at 1 site 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 10 inclusion and 5 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: stopped early, as of the sponsor's last update on 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: This study stopped due to slow accrual.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 year progression-free survival rate. (time frame: 2 Year after initial surgery). 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 9 May 2014.