Metastatic MelanomaNCT00716560
Nausea and Vomiting In Patients Receiving Consecutive Days of Cisplatin
An observational study of Metastatic Melanoma and Nausea, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
The purpose of this study is to observe the incidence of nausea with systemic chemotherapy that includes consecutive days (more than one day)of cisplatin medication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma, Nausea
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Mar 2009
- Phase
- Observational
- 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
Study population: University practice patients with metastatic melanoma
Who may be able to join
- confirmed diagnosis metastatic melanoma
- 18 years and older
- undergoing chemotherapy with Dartmouth regimen
- medically stable to receive chemotherapy per physical and clinical laboratory tests
Who cannot join
- No medical conditions that interfere with assessment of nausea and vomiting during chemotherapy
- No cognitive disorder that impairs symptom assessment
- No other investigational agent
- Inability to swallow medications for nausea and vomiting
- No gastric outlet obstruction
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
The purpose of this study is to observe the incidence of nausea with systemic chemotherapy that includes consecutive days (more than one day)of cisplatin medication.
Read the detailed description
Questionnaires are completed on week of chemotherapy treatment referred to as Dartmouth regimen.
- Conditions
- Metastatic Melanoma, Nausea
- Medical subject headings
- Melanoma, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Metastatic melanoma treatment with Dartmouth regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine incidence of nausea when receiving Dartmouth regimen chemotherapy for metastatic melanoma
Measured: Week of treatment
Secondary outcomes (1)
Assess the impact of systemic chemotherapy with Dartmouth regimen on quality of life of patients
Measured: week of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startMay 2005
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Administratively terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Takami Sato, M.D.,Ph.D., Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716560
- Sponsor's protocol ID
- 05C.202
- Other IDs
- 2004-101, 0402005015, JT 1069
- Status last verified
- May 2025
- First submitted
- 14 Jul 2008
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nausea and Vomiting In Patients Receiving Consecutive Days of Cisplatin
- ClinicalTrials.gov ID
- NCT00716560
- Acronym / sponsor ID
- 05C.202
- Conditions
- Metastatic Melanoma, Nausea
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Administratively terminated.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- May 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 16 Jul 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 observe the incidence of nausea with systemic chemotherapy that includes consecutive days (more than one day)of cisplatin medication.
Detailed description
Questionnaires are completed on week of chemotherapy treatment referred to as Dartmouth regimen.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | –Metastatic melanoma treatment with Dartmouth regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University practice patients with metastatic melanoma
Key inclusion criteria (4 listed)
- confirmed diagnosis metastatic melanoma
- 18 years and older
- undergoing chemotherapy with Dartmouth regimen
- medically stable to receive chemotherapy per physical and clinical laboratory tests
Key exclusion criteria (5 listed)
- No medical conditions that interfere with assessment of nausea and vomiting during chemotherapy
- No cognitive disorder that impairs symptom assessment
- No other investigational agent
- Inability to swallow medications for nausea and vomiting
- No gastric outlet obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine incidence of nausea when receiving Dartmouth regimen chemotherapy for metastatic melanoma
Time frame: Week of treatment
1 secondary outcome
Assess the impact of systemic chemotherapy with Dartmouth regimen on quality of life of patients
Time frame: week of treatment
Results and safety
The study was stopped early (reason given: Administratively terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Kimmel Cancer Center at Thomas Jefferson UniversityLink provided by the sponsor.
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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.
Takami Sato, M.D.,Ph.D. principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Melanoma and Nausea, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University 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 4 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 6 May 2025. 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.
Are results available for this study?
The study was stopped early (reason given: Administratively terminated.). 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?
Determine incidence of nausea when receiving Dartmouth regimen chemotherapy for metastatic melanoma (time frame: Week of treatment). 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 6 May 2025.