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Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT01009515
Recruitment Status : Terminated (Low accrual; target accrual not met)
First Posted : November 6, 2009
Results First Posted : November 3, 2015
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

Study Description
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Brief Summary:
The number of melanoma cases has been steadily increasing over the past few decades. For many patients with metastatic melanoma, there are no effective therapies. The goal of this study is to determine whether a combination drug treatment of carboplatin, paclitaxel and temozolomide is effective in the treatment of metastatic or recurrent melanoma.

Condition or disease Intervention/treatment Phase
Melanoma Drug: Paclitaxel, carboplatin, temozolomide Phase 2

Detailed Description:
Over the past several decades, significant research has been conducted to try to identify active chemotherapeutic agents for the treatment of melanoma. The rationale for combining taxanes and platinum agents is that both have activity in melanoma; in vitro and clinical data suggest synergy between these drugs when used in combination in a wide variety of tumors, including melanoma; and the toxicity profiles of these agents do not overlap. Temozolomide (a drug approved for the treatment of melanoma) has been combined with other drugs, including taxanes and platinums, in previous clinical trials for melanoma. Specifically, a previous phase I study of the combination of temozolomide, paclitaxel, and carboplatin in melanoma showed objective responses. The efficacy of this combination is now being studied in this phase II trial.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma
Study Start Date : August 2009
Actual Primary Completion Date : September 2013
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Chemotherapy Combination
Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.
 Drug: Paclitaxel, carboplatin, temozolomide
Combination chemotherapy was administered for up to 6 cycles


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 6 months ]
    Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The Objective Response Rate (ORR) is the sum of the percentages of patients achieving CR or PR.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 2 years ]
    The time from treatment initiation to death by any cause.

  2. Safety Profile [ Time Frame: Up to 30 days after last on-study treatment, for up to 2 years ]
    All toxicities encountered during the study by patients who receive at least one on-study treatment will be graded according to the NCI CTCAE (Version 3.0). The number of patients experiencing adverse events will be reported according to grade.

  3. Time to Progression [ Time Frame: 2 years ]
    The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients with biopsy proven advanced melanoma are eligible if there is measurable disease.
  • Patients must have a life expectancy of at least 12 weeks.
  • Prior surgery, immunotherapy, minimal chemotherapy (1 drug for less than 4 months), or radiotherapy for primary tumor is acceptable but must be completed at least 4 weeks from study entry, and patient should have completely recovered from such procedures.
  • Patients must have a Zubrod performance status of 0-2.
  • Patients must sign an informed consent.
  • Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of ≥ 1500 cells/mm3, hemoglobin > 8 g/dl, platelet count ≥ 100 000/mm3.
  • Patients should have a normal hepatic function with a total bilirubin < 1.5 the upper limit of normal (ULN) and serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) < 2 times the upper limit of normal (ULN),and adequate renal function as defined by a serum creatinine ≤ 1.5 times the ULN.
  • Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and at least for 3 months.
  • Patients with brain metastases are eligible if they have been appropriately treated, are asymptomatic

Exclusion Criteria:

  • Pregnant women or nursing mothers are not eligible.
  • Patients must not receive any other concurrent chemotherapy or radiation during this trial.
  • Patients with severe medical problems that would interfere with the therapy are not eligible.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01009515


Locations
United States, New Mexico
Hematology Oncology Associates
Albuquerque, New Mexico, United States, 87106
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
The Cancer Center at Presbyterian
Albuquerque, New Mexico, United States, 87110
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
Principal Investigator: Montasur Shaheen, MD University of New Mexico
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
University of New Mexico Cancer Center  This link exits the ClinicalTrials.gov site
New Mexico Cancer Care Alliance  This link exits the ClinicalTrials.gov site

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT01009515     History of Changes
Other Study ID Numbers: INST 0903
NCI-2011-01939 ( Registry Identifier: NCI CTRP )
First Posted: November 6, 2009    Key Record Dates
Results First Posted: November 3, 2015
Last Update Posted: October 18, 2017
Last Verified: October 2015

Keywords provided by New Mexico Cancer Care Alliance:
metastatic
melanoma
skin cancer
 paclitaxel
carboplatin
temozolomide

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