Mixed Mullerian Tumors of the UterusPhase 2NCT00476086
Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus
A Phase 2 study testing Gemcitabine, Oxaliplatin and Radiation in people with Mixed Mullerian Tumors of the Uterus, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The purpose of this research study is to determine the feasibility and safety of giving the combination of oxaliplatin and gemcitabine followed by radiation therapy and to learn whether or not this drug combined with radiation therapy works in treating women with Mullerian tumors of the uterus. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mixed Mullerian Tumors of the Uterus
- What is being tested?
- Gemcitabine, Oxaliplatin and Radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2006to Dec 2015
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgically staged and histologically confirmed diagnosis of MMMT
- 18 years of age or older
- ECOG Performance Score of 0-2
- Adequate bone marrow function
- Adequate renal function
- Adequate hepatic function
- Patients must be recovered from both the acute and late effects of any prior surgery
Who cannot join
- Patients with an active infection
- Patients with CNS metastases
- History of prior malignancy within the past 5 years except curatively treated basal cell carcinoma of the skin, or cervical intraepithelial neoplasia
- Known hypersensitivity to any of the components of oxaliplatin or gemcitabine
- Prior radiation to the pelvis
- Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days
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- Peripheral neuropathy greater or equal to Grade 2
- Stage IV visceral disease (lung and liver metastases at presentation)
- 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
- Known HIV or Hepatitis B or C (active, previously treated or both)
- Pregnant or breast feeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02215
About this study
Official title: A Phase II Study of Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus
The purpose of this research study is to determine the feasibility and safety of giving the combination of oxaliplatin and gemcitabine followed by radiation therapy and to learn whether or not this drug combined with radiation therapy works in treating women with Mullerian tumors of the uterus.
Read the detailed description
OBJECTIVES:
Primary To determine the feasibility of dual modality therapy described as cytotoxic therapy followed by radiation therapy for the management of Malignant Mixed Mullerian Tumors (MMMTs).
Secondary
- To describe the response rate by Response Evaluation Criteria in Solid Tumors
STATISTICAL DESIGN:
This study used a two-stage design to evaluate feasibility of oxaliplatin and gemcitabine prior to radiation therapy defined as completing 3 cycles of chemotherapy. The null and alternative therapy completion rates were 25% and 50%. If 3 or more participants enrolled in the stage one cohort (n=9 participants) complete therapy than accrual would proceed to stage two (n=15 participants). If therapy was completed by at least 10 participants in the final set of 24 evaluable participants then this regimen would be deemed worthy of further study. This design had 80% power given one-sided type I error of 5% with the probability of stopping early 0.60.
- Conditions
- Mixed Mullerian Tumors of the Uterus
- Being tested
- Gemcitabine, Oxaliplatin, Radiation
- Keywords
- oxaliplatin, gemcitabine, MMMT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
OxaliplatinDrug
Also called Eloxatin
RadiationRadiation
| Study group | Role | What they receive |
|---|---|---|
| Oxaliplatin/ Gemcitabine Then Radiation | Experimental | Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed. Receives: Drug: Gemcitabine; Drug: Oxaliplatin; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy Completion Rate
Feasibility in this study was based on the chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of oxaliplatin and gemcitabine chemotherapy prior to radiation therapy.
Measured: 3 cycles of chemotherapy which approximates 3 months given the 28-day cycle
Secondary outcomes (1)
Radiation Therapy Completion Rate
Disease was evaluated radiologically at baseline and every X cycles on treatment; Treatment continued if radiological exam showed no progressive disease
Measured: Radiation therapy was within 4-6 weeks of last chemotherapy dose. Participants received up to 5 weeks of radiation therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startAug 2006
- Primary completionMar 2012
- Study completionDec 2015
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 Mixed Mullerian Tumors of the UterusStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Brigham and Women's Hospital, Massachusetts General Hospital
- Responsible party
- Principal investigator, Susana M. Campos, MD, Dana-Farber Cancer Institute
- Investigators
- Susana Campos, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476086
- Sponsor's protocol ID
- 06-063
- Status last verified
- Jul 2018
- First submitted
- 17 May 2007
- Last updated
- 24 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus
- ClinicalTrials.gov ID
- NCT00476086
- Acronym / sponsor ID
- 06-063
- Conditions
- Mixed Mullerian Tumors of the Uterus
- Keywords
- oxaliplatin, gemcitabine, MMMT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Sanofi, Brigham and Women's Hospital, Massachusetts General Hospital
- Study start
- Aug 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 May 2007 (estimated)
- Results
- Posted 13 Apr 2016
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 research study is to determine the feasibility and safety of giving the combination of oxaliplatin and gemcitabine followed by radiation therapy and to learn whether or not this drug combined with radiation therapy works in treating women with Mullerian tumors of the uterus.
Detailed description
OBJECTIVES:
Primary To determine the feasibility of dual modality therapy described as cytotoxic therapy followed by radiation therapy for the management of Malignant Mixed Mullerian Tumors (MMMTs).
Secondary
- To describe the response rate by Response Evaluation Criteria in Solid Tumors
STATISTICAL DESIGN:
This study used a two-stage design to evaluate feasibility of oxaliplatin and gemcitabine prior to radiation therapy defined as completing 3 cycles of chemotherapy. The null and alternative therapy completion rates were 25% and 50%. If 3 or more participants enrolled in the stage one cohort (n=9 participants) complete therapy than accrual would proceed to stage two (n=15 participants). If therapy was completed by at least 10 participants in the final set of 24 evaluable participants then this regimen would be deemed worthy of further study. This design had 80% power given one-sided type I error of 5% with the probability of stopping early 0.60.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxaliplatin/ Gemcitabine Then Radiation | Experimental | Drug: Gemcitabine, Drug: Oxaliplatin, Radiation: RadiationPatients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Surgically staged and histologically confirmed diagnosis of MMMT
- 18 years of age or older
- ECOG Performance Score of 0-2
- Adequate bone marrow function
- Adequate renal function
Key exclusion criteria (11 listed)
- Patients with an active infection
- Patients with CNS metastases
- History of prior malignancy within the past 5 years except curatively treated basal cell carcinoma of the skin, or cervical intraepithelial neoplasia
- Known hypersensitivity to any of the components of oxaliplatin or gemcitabine
- Prior radiation to the pelvis
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 |
|---|---|---|
| GemcitabineAlso: Gemzar | Drug | Oxaliplatin/ Gemcitabine Then Radiation |
| OxaliplatinAlso: Eloxatin | Drug | Oxaliplatin/ Gemcitabine Then Radiation |
| Radiation | Radiation | Oxaliplatin/ Gemcitabine Then Radiation |
Primary outcome
Chemotherapy Completion Rate
Time frame: 3 cycles of chemotherapy which approximates 3 months given the 28-day cycle
Feasibility in this study was based on the chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of oxaliplatin and gemcitabine chemotherapy prior to radiation therapy.
1 secondary outcome
Radiation Therapy Completion Rate
Time frame: Radiation therapy was within 4-6 weeks of last chemotherapy dose. Participants received up to 5 weeks of radiation therapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Susana Campos, MD principal investigator
Dana-Farber Cancer Institute
2 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 Gemcitabine, Oxaliplatin and Radiation in people with Mixed Mullerian Tumors of the Uterus, run by Dana-Farber Cancer Institute at 2 sites 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 7 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: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 13 Apr 2016). 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?
Chemotherapy Completion Rate (time frame: 3 cycles of chemotherapy which approximates 3 months given the 28-day cycle). 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 24 Aug 2018.