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Paclitaxel and Carboplatin or Temozolomide in Treating Patients With Stage IV Melanoma

This study has been terminated.
(Slow accrual.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00568451
First Posted: December 6, 2007
Last Update Posted: December 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving paclitaxel together with carboplatin is more effective than giving temozolomide alone in treating patients with melanoma.

PURPOSE: This phase II trial is studying the side effects and how well giving paclitaxel together with carboplatin or giving temozolomide alone works in treating patients with stage IV melanoma.


Condition Intervention Phase
Melanoma (Skin) Drug: carboplatin Drug: paclitaxel Drug: temozolomide Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Releasing the Cancer Patient's Immune System From Down-regulation With Timed Delivery of Standard Chemotherapy

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Number of Participants With an Objective Tumor Status of Either a Complete Response(CR) or Partial Response (PR), According to RECIST (Response Evaluation Criteria in Solid Tumors) Criteria [ Time Frame: Every other cycle of therapy (cycle=4 weeks) for the first 6 cycles of treatment ]

    Response that was noted on 2 consecutive evaluations for at least 4 weeks apart.

    CR: Disappearance of all target lesions; PR: At least a 30 percent of decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Target lesions: All measurable lesions up to a maximum of 10 lesions representative of all involved organs.



Secondary Outcome Measures:
  • Time to Disease Progression [ Time Frame: up to 2 years ]
    Time to disease progression was defined as the time from registration to documentation of disease progression. Disease progression was measured according to the RECIST criteria. Progression: At least a 20 percent increase in the sum of of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

  • Survival Time [ Time Frame: up to 2 years ]
    Survival time was defined as the time from registration to death due to any cause.

  • Duration of Response for All Evaluable Patients Who Have Achieved an Objective Response [ Time Frame: up to 2 years ]
    Duration of response was defined as the date at which the participant's objective status was first noted to be either a Complete Response or Partial Response to the date the progression was documented.

  • Number of Participants Who Experienced Changes in Immunologic Profile (CD4/CD25+ Cells, CD4/Fox-p3+ T Cells) Within a Treatment [ Time Frame: up to 2 years ]
    Time series plot of the number of circulating cells will be constructed. The resulting plots will be visually inspected for trends within and between treatments. For each cell type, a point and an interval estimate of the number of participants (receiving a given treatment) who had at least a 2-fold increase in the number of circulating cells of that type will be constructed using the properties of the binomial distribution.

  • Number of Participants Who Experienced Changes in Immunologic Profile (MART-1, Tyrosinase, and gp100) Within a Treatment [ Time Frame: up to 2 years ]
    For those patients who are HLA-A2+, the maximum post-treatment levels of MART-1, tyrosinase, and gp100 will be determined. For each of these specific melanoma specific antigens, the number of participants (within a given treatment) who gained or maintained immunity based on the maximum post-treatment level of that specific melanoma specific antigen will be determined.

  • Number of Participants Who Experienced Changes in Immunologic Profile (IFNγ Producing Peptide Specific CTLs) Within a Treatment [ Time Frame: up to 2 years ]
    For each patient, a time series plot of the number of IFNγ producing peptide specific CTLs will be constructed. The resulting plots will be visually inspected for trends within and between treatments. A point and an interval estimate of the number of participants (receiving a given treatment) who had at least a 2-fold increase in the number of the number of IFNγ producing peptide specific CTLs will be constructed using the properties of the binomial distribution.


Enrollment: 12
Study Start Date: June 2006
Study Completion Date: April 2012
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PC (previously treated)
Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
Drug: carboplatin
AUC=2 intravenously on days 1, 8 and 15. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal
Drug: paclitaxel
100mg/m^2 intravenously on days 1, 8 and 15. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal
Other Name: Taxol
Experimental: PC (chemo naive)
Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
Drug: carboplatin
AUC=2 intravenously on days 1, 8 and 15. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal
Drug: paclitaxel
100mg/m^2 intravenously on days 1, 8 and 15. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal
Other Name: Taxol
Experimental: TMZ (previously treated)
Previously chemotherapy treated cohorts: Temozolomide (TMZ)
Drug: temozolomide
150mg/m^2 at cycle 1, 200mg/m^2 at cycle 2 and beyond, orally on days 1-5. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal. One treatment cycle=four weeks
Other Name: Temodar
Experimental: TMZ (chemo naive)
Chemotherapy-naive cohorts: Temozolomide (TMZ)
Drug: temozolomide
150mg/m^2 at cycle 1, 200mg/m^2 at cycle 2 and beyond, orally on days 1-5. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal. One treatment cycle=four weeks
Other Name: Temodar

Detailed Description:

OBJECTIVES:

  • To assess the anti-tumor activity and toxicity profile of timed delivery of conventional paclitaxel and carboplatin (PC) in patients with stage IV melanoma who have received prior chemotherapy for their metastatic disease.
  • To assess the anti-tumor activity and toxicity profile of timed delivery of conventional temozolomide (TMZ) chemotherapy in patients with stage IV melanoma who have received prior chemotherapy for their metastatic disease.
  • To assess the anti-tumor activity and toxicity profile of timed delivery of conventional PC in patients with stage IV melanoma who have not received prior chemotherapy for their metastatic disease.
  • To assess the anti-tumor activity and toxicity profile of timed delivery of conventional TMZ chemotherapy in patients with stage IV melanoma who have not received prior chemotherapy for their metastatic disease.
  • To evaluate the changes of T-regulator cells, melanoma-specific functional parameters as a function of time in all four patient cohorts.

OUTLINE: Patients are stratified according to prior chemotherapy for metastatic disease (yes vs no) and scheduled chemotherapy regimen (paclitaxel and carboplatin vs temozolomide).

Beginning at the predicted day of C-reactive peptide (CRP) peak levels, patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15 OR oral temozolomide alone on days 1-5. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection periodically for pharmacological studies. Samples are analyzed for CRP quantification via ELISA; presence and number of circulating blood T-regulator cells via immunophenotyping for CD4/CD25+ and CD4/fox-p3+ T cells; level of functional immunity against melanoma specific antigens (MART-1, tyrosinase, and gp100) and survivin in patients that are HLA-A2+ via intracellular staining; total number of cytotoxic T lymphocytes (CTLs) capable of reacting against melanoma targets via tetramer staining (Becton-Coulter); and quantification of interferon γ-producing, peptide-specific CTLs via multicolor conventional flow cytometry.

After completion of study treatment, patients are followed every 3 months for up to 2 years.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed metastatic melanoma

    • Stage IV disease
    • Progressive disease
    • No known standard therapy that is potentially curative or proven capable of extending life expectancy exists
  • Planning to undergo chemotherapy with paclitaxel and carboplatin OR temozolomide alone for progressive disease
  • Measurable disease as defined by RECIST criteria

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • ANC ≥ 1,500/mL
  • Platelet count ≥ 100,000/mL
  • Hemoglobin ≥ 9 g/dL
  • Creatinine ≤ 2.5 x upper limit of normal (ULN)
  • AST ≤ 3 x ULN
  • Alkaline phosphatase ≤ 3.0 x ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 month after completion of study therapy
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Active infection
    • NYHA class III or IV congestive heart failure
  • No history of other malignancy within the past 5 years except for basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
  • Willing to provide research blood samples

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior therapy
  • At least 4 weeks since prior radiotherapy
  • At least 4 weeks since prior chemotherapy (patients who received chemotherapy in the metastatic setting)

    • No prior chemotherapy treatment with agents similar to study drugs
  • No prior chemotherapy in the metastatic setting (for chemo-naive patients)
  • No concurrent enrollment in a different clinical study in which investigational procedures or agents are being used
  • No other concurrent investigational agents
  • No other concurrent chemotherapy or radiotherapy, including palliative radiotherapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568451


Locations
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Study Chair: Svetomir Markovic, MD, PhD Mayo Clinic
  More Information

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00568451     History of Changes
Other Study ID Numbers: MC057F
P30CA015083 ( U.S. NIH Grant/Contract )
MC057F ( Other Identifier: Mayo Clinic Cancer Center )
06-002547 ( Other Identifier: Mayo Clinic IRB )
NCI-2010-01794 ( Registry Identifier: CTRP )
First Submitted: December 5, 2007
First Posted: December 6, 2007
Results First Submitted: November 1, 2011
Results First Posted: March 30, 2012
Last Update Posted: December 30, 2015
Last Verified: March 2014

Keywords provided by Mayo Clinic:
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Paclitaxel
Temozolomide
Albumin-Bound Paclitaxel
Carboplatin
Dacarbazine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents