Ovarian CancerPhase 2NCT00582205
Feasibility Trial of Intraperitoneal Chemotherapy for Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma
A Phase 2 study testing Paclitaxel, Cisplatin IP in people with Ovarian Cancer and Fallopian Tube Cancer, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this study is to evaluate giving chemotherapy drugs directly into the abdomen (belly) along with intravenous administration. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- What is being tested?
- Paclitaxel, Cisplatin IP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stage IA, IB, IC, II, III, IV and recurrent platinum sensitive epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma, or ovarian carcinosarcoma. Histologic subtypes which are eligible include serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's tumor, adenocarcinoma (not otherwise specified), and carcinosarcoma.
- Patients with advanced endometrial carcinoma, of any histology, including endometrioid adenocarcinoma, clear cell adenocarcinoma, and serous papillary carcinoma.
- Patients with uterine carcinosarcoma of any stage are eligible.
Who cannot join
- Patients with epithelial ovarian carcinoma of low malignant potential (borderline carcinomas).
- Patients with septicemia, severe infection, or acute hepatitis.
- Patients with prior malignancy or cancer treatment within the last five years.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Feasibility Trial of Intraperitoneal Chemotherapy in Stage IA, IB, IC, II, III, IV and Recurrent Platinum Sensitive Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma and Stage III and IV Uterine Cancer
The purpose of this study is to evaluate giving chemotherapy drugs directly into the abdomen (belly) along with intravenous administration.
Read the detailed description
Giving chemotherapy directly into the abdomen is called intraperitoneal (IP) chemotherapy. Because ovarian, fallopian, primary peritoneal and uterine cancer spread in the abdominal cavity, giving chemotherapy drugs by infusion into the abdominal cavity may result in a greater dose of the drugs reaching the tumor cells. Intraperitoneal treatments will be administered through an implantable peritoneal catheter. These catheters are to be inserted into the peritoneal cavity, tunneled through the subcutaneous tissue, and connected to an implantable port, which is placed in the subcutaneous tissue of the anterior, inferior thorax.
- Being tested
- Paclitaxel, Cisplatin IP
- Keywords
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Uterine Cancer, Intraperitoneal Chemotherapy, IP Chemotherapy, Gynecologic Cancer, Women's Cancer, Cisplatin, Paclitaxel, Recurrent Platinum Sensitive Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel, Cisplatin IPDrug
Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel, Cisplatin IP | Experimental | There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy Receives: Drug: Paclitaxel, Cisplatin IP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy.
Measured: 3 years
Secondary outcomes (1)
Number of Patients With Dose Reductions or Dose Delays Due to Neuropathy or Toxicity
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startJan 2006
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Study completed per investigator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joan Walker, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582205
- Sponsor's protocol ID
- WalkerIP
- Status last verified
- Apr 2021
- First submitted
- 19 Dec 2007
- Last updated
- 19 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of Intraperitoneal Chemotherapy in Stage IA, IB, IC, II, III, IV and Recurrent Platinum Sensitive Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma and Stage III and IV Uterine Cancer
- ClinicalTrials.gov ID
- NCT00582205
- Acronym / sponsor ID
- WalkerIP
- Keywords
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Uterine Cancer, Intraperitoneal Chemotherapy, IP Chemotherapy, Gynecologic Cancer, Women's Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study completed per investigator.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Dec 2007 (estimated)
- Results
- Posted 18 May 2017
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 evaluate giving chemotherapy drugs directly into the abdomen (belly) along with intravenous administration.
Detailed description
Giving chemotherapy directly into the abdomen is called intraperitoneal (IP) chemotherapy. Because ovarian, fallopian, primary peritoneal and uterine cancer spread in the abdominal cavity, giving chemotherapy drugs by infusion into the abdominal cavity may result in a greater dose of the drugs reaching the tumor cells. Intraperitoneal treatments will be administered through an implantable peritoneal catheter. These catheters are to be inserted into the peritoneal cavity, tunneled through the subcutaneous tissue, and connected to an implantable port, which is placed in the subcutaneous tissue of the anterior, inferior thorax.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel, Cisplatin IP | Experimental | Drug: Paclitaxel, Cisplatin IPThere is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with stage IA, IB, IC, II, III, IV and recurrent platinum sensitive epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma, or ovarian carcinosarcoma. Histologic subtypes which are eligible include serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's tumor, adenocarcinoma (not otherwise specified), and carcinosarcoma.
- Patients with advanced endometrial carcinoma, of any histology, including endometrioid adenocarcinoma, clear cell adenocarcinoma, and serous papillary carcinoma.
- Patients with uterine carcinosarcoma of any stage are eligible.
Key exclusion criteria (3 listed)
- Patients with epithelial ovarian carcinoma of low malignant potential (borderline carcinomas).
- Patients with septicemia, severe infection, or acute hepatitis.
- Patients with prior malignancy or cancer treatment within the last five years.
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 |
|---|---|---|
| Paclitaxel, Cisplatin IPPaclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles | Drug | Paclitaxel, Cisplatin IP |
Primary outcome
Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy.
Time frame: 3 years
1 secondary outcome
Number of Patients With Dose Reductions or Dose Delays Due to Neuropathy or Toxicity
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joan Walker, MD principal investigator
University of Oklahoma
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 Paclitaxel, Cisplatin IP in people with Ovarian Cancer and Fallopian Tube Cancer, run by University of Oklahoma at 1 site in United States.
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 3 inclusion and 3 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 19 May 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 18 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Who Are Able to Receive 6 Cycles of Intraperitoneal Cisplatin Chemotherapy. (time frame: 3 years). 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 19 May 2021.