Ovarian CancerPhase 1NCT00692900
Safety Study Involving Oxaliplatin With Docetaxel for Recurrent Ovarian,Primary Peritoneal, and Fallopian Tube Cancer
A Phase 1 study testing intravenous docetaxel with intraperitoneal oxaliplatin and intravenous oxaliplatin with intraperitoneal docetaxel in people with Ovarian Cancer and Peritoneal Cancer, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to determine the safest and maximum tolerated dosing regimens for intraperitoneal oxaliplatin with intravenous docetaxel and intravenous oxaliplatin with intraperitoneal docetaxel for recurrent ovarian, primary peritoneal, or fallopian tube cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- What is being tested?
- intravenous docetaxel with intraperitoneal oxaliplatin and intravenous oxaliplatin with intraperitoneal docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Oct 2013
- Phase
- Phase 1
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent histologically confirmed platinum-sensitive or platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer
- Subjects may not have had > 3 prior regimens and must not have had a platinum or taxane agent within the past 6 months. Last chemotherapy must have been > 4 weeks prior to enrollment. Subjects may not have had prior whole abdomen or pelvic radiation. Patients may not have had > 6 cycles of an alkylating agent or > 450 mg/m2 of doxorubicin.
- ECOG Performance Score of ≤2 (Appendix A)
- Adequate bone marrow as evidenced by:
- Absolute neutrophil count > or equal to 1,500/uL
- Hemoglobin > or equal to 8 g/dl
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- Platelet count > or equal to 100,000/uL
- Adequate renal function as evidenced by serum creatinine < 1.5 mg/dL
- Adequate hepatic function as evidenced by:
- Serum total bilirubin < 1.5 mg/dL
- Alk Phos, AST/ALT must be < 3x ULN or <5x ULN if hepatic mets.
- AST/ALT < 3X the ULN for the reference lab
- Patients must be recovered from both the acute and late effects of any prior surgery, radiotherapy or other antineoplastic therapy
- Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial.
- Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method)
Who cannot join
- Patients with an active infection or with a fever > 101.30 F within 3 days of the first scheduled day of protocol treatment
- Patients with active extra-abdominal metastases
- Patients with active CNS metastases. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for 3 weeks are eligible for the trial
- History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin or cervical intra-epithelial neoplasia
- Patients with known hypersensitivity to any of the components of docetaxel or oxaliplatin
- Patients who received pelvic or abdominal radiotherapy
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- Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
- Peripheral neuropathy ≤ Grade 2
- Patients who are pregnant or lactating
- Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
- History of allogeneic transplant
- Known HIV or Hepatitis B or C (active, previously treated or both)
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Phase I Dose-Escalation Parallel Studies of Intraperitoneal Oxaliplatin With Intravenous Docetaxel and Intravenous Oxaliplatin With Intraperitoneal Docetaxel in Platinum-Sensitive or Platinum-Resistant Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
The purpose of this study is to determine the safest and maximum tolerated dosing regimens for intraperitoneal oxaliplatin with intravenous docetaxel and intravenous oxaliplatin with intraperitoneal docetaxel for recurrent ovarian, primary peritoneal, or fallopian tube cancer.
Read the detailed description
This is a non-randomized, open-label Phase I trial in patients with previously treated, recurrent ovarian, primary peritoneal, or fallopian tube cancer. Patients may have either platinum -sensitive (relapse > 12 months from primary therapy) or platinum-resistant (relapse ≤ 12 months from primary therapy) disease.
Up to 20 patients will be enrolled into each of the following arms:
- Arm 1 patients will receive intravenous docetaxel at standard dosing of 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal oxaliplatin on day #2 until maximum tolerated dose is achieved.
- Arm 2 patients will receive intravenous oxaliplatin at standard dosing of 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal docetaxel on day #2 until maximum tolerated dose is achieved.
Treatment will be repeated every 3 weeks until disease progression, intolerable toxicity.
- Conditions
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Being tested
- intravenous docetaxel with intraperitoneal oxaliplatin, intravenous oxaliplatin with intraperitoneal docetaxel
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous docetaxel with intraperitoneal oxaliplatinDrug
IV docetaxel 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal oxaliplatin escalating from 50 mg/m2 on day #2. Cycles of treatment will be repeated every 3 weeks until disease progression or intolerable toxicity occurs.
intravenous oxaliplatin with intraperitoneal docetaxelDrug
IV oxaliplatin 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal docetaxel escalating from 50 mg/m2 on day #2. Cycles of treatment will be repeated every 3 weeks until disease progression or intolerable toxicity occurs.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | intravenous (IV) docetaxel and intraperitoneal (IP) oxaliplatin Receives: Drug: intravenous docetaxel with intraperitoneal oxaliplatin |
| 2 | Experimental | intravenous (IV) oxaliplatin and intraperitoneal(IP) docetaxel Receives: Drug: intravenous oxaliplatin with intraperitoneal docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safest and maximum tolerated dose regimen for IV oxaliplatin with intraperitoneal docetaxel and IV oxaliplatin with intraperitoneal docetaxel in patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer.
Measured: 18 months
Secondary outcomes (1)
To assess quality of life
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Robert Edwards, University of Pittsburgh
- Investigators
- Robert P Edwards, MD, Principal investigator, University of Pittsburgh Medical CenterKristin Zorn, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692900
- Sponsor's protocol ID
- OX-06-009
- Status last verified
- Mar 2020
- First submitted
- 4 Jun 2008
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose-Escalation Parallel Studies of Intraperitoneal Oxaliplatin With Intravenous Docetaxel and Intravenous Oxaliplatin With Intraperitoneal Docetaxel in Platinum-Sensitive or Platinum-Resistant Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT00692900
- Acronym / sponsor ID
- OX-06-009
- Conditions
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Dec 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 6 Jun 2008 (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 determine the safest and maximum tolerated dosing regimens for intraperitoneal oxaliplatin with intravenous docetaxel and intravenous oxaliplatin with intraperitoneal docetaxel for recurrent ovarian, primary peritoneal, or fallopian tube cancer.
Detailed description
This is a non-randomized, open-label Phase I trial in patients with previously treated, recurrent ovarian, primary peritoneal, or fallopian tube cancer. Patients may have either platinum -sensitive (relapse > 12 months from primary therapy) or platinum-resistant (relapse ≤ 12 months from primary therapy) disease.
Up to 20 patients will be enrolled into each of the following arms:
- Arm 1 patients will receive intravenous docetaxel at standard dosing of 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal oxaliplatin on day #2 until maximum tolerated dose is achieved.
- Arm 2 patients will receive intravenous oxaliplatin at standard dosing of 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal docetaxel on day #2 until maximum tolerated dose is achieved.
Treatment will be repeated every 3 weeks until disease progression, intolerable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: intravenous docetaxel with intraperitoneal oxaliplatinintravenous (IV) docetaxel and intraperitoneal (IP) oxaliplatin |
| 2 | Experimental | Drug: intravenous oxaliplatin with intraperitoneal docetaxelintravenous (IV) oxaliplatin and intraperitoneal(IP) docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Recurrent histologically confirmed platinum-sensitive or platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer
- Subjects may not have had > 3 prior regimens and must not have had a platinum or taxane agent within the past 6 months. Last chemotherapy must have been > 4 weeks prior to enrollment. Subjects may not have had prior whole abdomen or pelvic radiation. Patients may not have had > 6 cycles of an alkylating agent or > 450 mg/m2 of doxorubicin.
- ECOG Performance Score of ≤2 (Appendix A)
- Adequate bone marrow as evidenced by:
- Adequate renal function as evidenced by serum creatinine < 1.5 mg/dL
Key exclusion criteria (12 listed)
- Patients with an active infection or with a fever > 101.30 F within 3 days of the first scheduled day of protocol treatment
- Patients with active extra-abdominal metastases
- Patients with active CNS metastases. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for 3 weeks are eligible for the trial
- History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin or cervical intra-epithelial neoplasia
- Patients with known hypersensitivity to any of the components of docetaxel or oxaliplatin
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 |
|---|---|---|
| intravenous docetaxel with intraperitoneal oxaliplatinIV docetaxel 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal oxaliplatin escalating from 50 mg/m2 on day #2. Cycles of treatment will be repeated every 3 weeks until disease progression or intolerable toxicity occurs. | Drug | 1 |
| intravenous oxaliplatin with intraperitoneal docetaxelIV oxaliplatin 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal docetaxel escalating from 50 mg/m2 on day #2. Cycles of treatment will be repeated every 3 weeks until disease progression or intolerable toxicity occurs. | Drug | 2 |
Primary outcome
To determine the safest and maximum tolerated dose regimen for IV oxaliplatin with intraperitoneal docetaxel and IV oxaliplatin with intraperitoneal docetaxel in patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer.
Time frame: 18 months
1 secondary outcome
To assess quality of life
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
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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.
Robert P Edwards, MD principal investigator
University of Pittsburgh Medical Center
Kristin Zorn, MD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing intravenous docetaxel with intraperitoneal oxaliplatin and intravenous oxaliplatin with intraperitoneal docetaxel in people with Ovarian Cancer and Peritoneal Cancer, run by University of Pittsburgh 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 15 inclusion and 12 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: finished, as of the sponsor's last update on 12 Mar 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the safest and maximum tolerated dose regimen for IV oxaliplatin with intraperitoneal docetaxel and IV oxaliplatin with intraperitoneal docetaxel in patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer. (time frame: 18 months). 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 12 Mar 2020.