Metastatic MelanomaPhase 2NCT00256282
Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma
A Phase 2 study testing Vinorelbine, Docetaxel and Sargramostim in people with Metastatic Melanoma, run by John P. Fruehauf at 1 site in United States.
Trial summary
This is a Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in subjects who have metastatic melanoma which has advanced beyond the point at which local therapies such as surgery or radiation therapy would be helpful. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Vinorelbine, Docetaxel and Sargramostim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Aug 2012
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18
- Karnofsky Performance Status (KFS) of greater than or equal to 70
- Laboratory values (performed in 14 days, inclusive prior to study drug administration):
- Absolute neutrophil count (ANC) >1500/mm3
- Platelet count >100,000/mm3
- Hemoglobin > 10 g/dl
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- Blood urea nitrogen (BUN) and serum creatinine < 0.5 times the upper limit of laboratory normal
- Total and direct bilirubin < 1.5 times the upper limit of laboratory normal
- Serum glutamic-oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase(SGPT) < 3 times the upper limit of laboratory normal
- Alkaline phosphatase < 3 times upper limit of laboratory normal
- Life expectancy of greater than 12 weeks
- Written informed consent
Who cannot join
- No recovery from all active toxicities of prior therapies
- Surgery within 1 week prior to study drug administration, providing acute surgical toxicity is resolved
- Subjects within acute infection treated with intravenous antibiotics
- Frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction)
- Concurrent malignancies at other sites with the exception of surgically cured carcinoma in situ (CIS ) of the cervix, basal or squamous cell carcinoma of the skin, and prior malignancies which have not required anit-tumor treatment within the preceding 24 months
- Known HIV-positivity or AIDS-related illness
Show all 12Show fewer
- Women of childbearing potential who are not using an effective method of contraception (eligible patients must have a negative urine pregnancy test 24 hours prior to administration of study drug and be practicing medically approved contraceptive precautions)
- Men who do not use an effective method of contraception.
- Chemotherapy within four weeks prior to study drug administration or biologic therapy/immunotherapy within two weeks prior to study drug administration
- Completion of radiation therapy, interstitial brachytherapy, or radiosurgery within 4 weeks prior to study drug administration (patients with brain metastases from melanoma must have completed radiotherapy to the brain at least 3 weeks before study commences)
- Bone metastases as sole reason for Stage IV disease
- Karnofsky Performance Status of less than or equal to 60
Trial locations and contacts
1 site in 1 country.
United States1 site
Chao Family Comprehensive Cancer Center
Orange, California, 92868
About this study
Official title: A Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in Patients With Metastatic Malignant Melanoma
This is a Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in subjects who have metastatic melanoma which has advanced beyond the point at which local therapies such as surgery or radiation therapy would be helpful. Without effective treatment, metastatic melanoma is usually a severe and fatal disease. Chemotherapy agents or combinations of chemotherapy agents have produced tumor shrinkage in some patients, which has occasionally persisted. This research involves treatment with a combination of chemotherapy drugs known to be active against melanoma alone. The investigational purpose of this study is to determine if the combination of docetaxel, vinorelbine and sargramostim will produce a response (complete or partial) in metastasis melanoma. The researchers also wants to find out what side effects are associated with this combination of drugs.
Read the detailed description
Annually in the U.S. there is an estimated 40,000 new cases of malignant melanoma and 7000 deaths. This disease is becoming more common with its incidence increasing at a more rapid rate in the past decade than that of any other cancer except lung cancer in women. Metastatic disease responds poorly to the usual treatments with only 2 out of 30 drugs tested, DTIC and nitrosoureas, showing response rates greater than 10%. Complete responses are rare.
Metastatic melanoma is a disease with few therapeutic options. Multi-agent chemotherapy with cisplatin (CDDP), Dacarbazine (DTIC), Carmustine (BCNU), with or without Tamoxifen, offers a 20% response rate but has failed to consistently demonstrate a significant improvement in overall survival (OS) or disease-free survival (DFS) when compared to a single agent DTIC.
Recently, investigators, in an effort to combine the activity of biologic response modifiers with chemotherapy, have developed combination biochemotherapy for metastatic melanoma. Legha et al reported an overall objective response rate of 64% with a 5-day biochemotherapy regimen. O'Day et al reported similar results (overall response rate of 57%) using a modified 5-day biochemotherapy regimen.
The above regimens all have significant toxicities and modest response rates. Clearly, more effective less toxic regimens are needed.
Vinorelbine tartrate (Navelbine) and Docetaxel (Taxotere) have both shown activity against melanoma. Additionally, the combination of both drugs has shown enhanced activity against melanoma.
- Conditions
- Metastatic Melanoma
- Being tested
- Vinorelbine, Docetaxel, Sargramostim
- Keywords
- Metastatic Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinorelbineDrug
Also called Navelbine, NSC-608210
30 mg/m2 IV over 6-10 min every 14 days
DocetaxelDrug
Also called Taxotere, RP56976, NSC-628503
40mg/m2 IV over 1 hour every 14 days
SargramostimDrug
Also called Recombinant GM-CSF, Leukine, Immunex, NSC-613795
250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel & Vinorelbine + Sargramostim | Experimental | Docetaxel, Vinorelbine, and Sargramostim Receives: Drug: Vinorelbine; Drug: Docetaxel; Drug: Sargramostim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) in Patients With AJCC Stage IV Metastatic Melanoma Treated With Docetaxel and Vinorelbine as First-line or Post-first Line (Salvage) Systemic Therapy
The primary endpoint is to evaluate the six-month progression-free survival (PFS) in patients with AJCC stage IV metastatic melanoma treated with docetaxel and vinorelbine as first-line or post-first line (salvage) systemic therapy. Progressive disease is defined as any new lesion or a greater than or equal to 20% increase in the largest perpendicular diameter of the sum of the T-lesions identified on contrast enhanced CT or MRI scan.
Measured: Six months from initial treatment
Secondary outcomes (1)
Percentage of Patients Alive at One Year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startApr 2003
- Primary completionAug 2012
- Study completionAug 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- John P. Fruehauf
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor-investigator, John P. Fruehauf, University of California, Irvine
- Investigators
- John P. Fruehauf, MD, PhD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256282
- Sponsor's protocol ID
- UCI 02-23
- Other IDs
- 2002-2763, NCI-2010-00217
- Status last verified
- Feb 2018
- First submitted
- 17 Nov 2005
- Last updated
- 3 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Eroglu Z, Kong KM, Jakowatz JG, Samlowski W, Fruehauf JP. Phase II clinical trial evaluating docetaxel, vinorelbine and GM-CSF in stage IV melanoma. Cancer Chemother Pharmacol. 2011 Oct;68(4):1081-7. doi: 10.1007/s00280-011-1703-z. Epub 2011 Jul 19.
PubMed 21769667
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in Patients With Metastatic Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00256282
- Acronym / sponsor ID
- UCI 02-23
- Conditions
- Metastatic Melanoma
- Keywords
- Metastatic Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- John P. FruehaufUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Apr 2003
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 21 Nov 2005 (estimated)
- Results
- Posted 3 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in subjects who have metastatic melanoma which has advanced beyond the point at which local therapies such as surgery or radiation therapy would be helpful. Without effective treatment, metastatic melanoma is usually a severe and fatal disease. Chemotherapy agents or combinations of chemotherapy agents have produced tumor shrinkage in some patients, which has occasionally persisted. This research involves treatment with a combination of chemotherapy drugs known to be active against melanoma alone. The investigational purpose of this study is to determine if the combination of docetaxel, vinorelbine and sargramostim will produce a response (complete or partial) in metastasis melanoma. The researchers also wants to find out what side effects are associated with this combination of drugs.
Detailed description
Annually in the U.S. there is an estimated 40,000 new cases of malignant melanoma and 7000 deaths. This disease is becoming more common with its incidence increasing at a more rapid rate in the past decade than that of any other cancer except lung cancer in women. Metastatic disease responds poorly to the usual treatments with only 2 out of 30 drugs tested, DTIC and nitrosoureas, showing response rates greater than 10%. Complete responses are rare.
Metastatic melanoma is a disease with few therapeutic options. Multi-agent chemotherapy with cisplatin (CDDP), Dacarbazine (DTIC), Carmustine (BCNU), with or without Tamoxifen, offers a 20% response rate but has failed to consistently demonstrate a significant improvement in overall survival (OS) or disease-free survival (DFS) when compared to a single agent DTIC.
Recently, investigators, in an effort to combine the activity of biologic response modifiers with chemotherapy, have developed combination biochemotherapy for metastatic melanoma. Legha et al reported an overall objective response rate of 64% with a 5-day biochemotherapy regimen. O'Day et al reported similar results (overall response rate of 57%) using a modified 5-day biochemotherapy regimen.
The above regimens all have significant toxicities and modest response rates. Clearly, more effective less toxic regimens are needed.
Vinorelbine tartrate (Navelbine) and Docetaxel (Taxotere) have both shown activity against melanoma. Additionally, the combination of both drugs has shown enhanced activity against melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel & Vinorelbine + Sargramostim | Experimental | Drug: Vinorelbine, Drug: Docetaxel, Drug: SargramostimDocetaxel, Vinorelbine, and Sargramostim |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age greater than or equal to 18
- Karnofsky Performance Status (KFS) of greater than or equal to 70
- Laboratory values (performed in 14 days, inclusive prior to study drug administration):
- Life expectancy of greater than 12 weeks
- Written informed consent
Key exclusion criteria (12 listed)
- No recovery from all active toxicities of prior therapies
- Surgery within 1 week prior to study drug administration, providing acute surgical toxicity is resolved
- Subjects within acute infection treated with intravenous antibiotics
- Frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction)
- Concurrent malignancies at other sites with the exception of surgically cured carcinoma in situ (CIS ) of the cervix, basal or squamous cell carcinoma of the skin, and prior malignancies which have not required anit-tumor treatment within the preceding 24 months
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 |
|---|---|---|
| VinorelbineAlso: Navelbine, NSC-60821030 mg/m2 IV over 6-10 min every 14 days | Drug | Docetaxel & Vinorelbine + Sargramostim |
| DocetaxelAlso: Taxotere, RP56976, NSC-62850340mg/m2 IV over 1 hour every 14 days | Drug | Docetaxel & Vinorelbine + Sargramostim |
| SargramostimAlso: Recombinant GM-CSF, Leukine, Immunex, NSC-613795250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days | Drug | Docetaxel & Vinorelbine + Sargramostim |
Primary outcome
Progression-free Survival (PFS) in Patients With AJCC Stage IV Metastatic Melanoma Treated With Docetaxel and Vinorelbine as First-line or Post-first Line (Salvage) Systemic Therapy
Time frame: Six months from initial treatment
The primary endpoint is to evaluate the six-month progression-free survival (PFS) in patients with AJCC stage IV metastatic melanoma treated with docetaxel and vinorelbine as first-line or post-first line (salvage) systemic therapy. Progressive disease is defined as any new lesion or a greater than or equal to 20% increase in the largest perpendicular diameter of the sum of the T-lesions identified on contrast enhanced CT or MRI scan.
1 secondary outcome
Percentage of Patients Alive at One Year
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21769667Eroglu Z, Kong KM, Jakowatz JG, Samlowski W, Fruehauf JP. Phase II clinical trial evaluating docetaxel, vinorelbine and GM-CSF in stage IV melanoma. Cancer Chemother Pharmacol. 2011 Oct;68(4):1081-7. doi: 10.1007/s00280-011-1703-z. Epub 2011 Jul 19.
- 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.
John P. Fruehauf, MD, PhD principal investigator
Chao Family Comprehensive Cancer Center
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 Vinorelbine, Docetaxel and Sargramostim in people with Metastatic Melanoma, run by John P. Fruehauf 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 12 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 3 May 2018. 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 3 May 2018). 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?
Progression-free Survival (PFS) in Patients With AJCC Stage IV Metastatic Melanoma Treated With Docetaxel and Vinorelbine as First-line or Post-first Line (Salvage) Systemic Therapy (time frame: Six months from initial treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00256282, which also lists 1 linked publication.
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 3 May 2018.