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

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.
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Drug: Paclitaxel, carboplatin, temozolomide
Combination chemotherapy was administered for up to 6 cycles
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- 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.
- Overall Survival [ Time Frame: 2 years ]The time from treatment initiation to death by any cause.
- 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.
- 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.

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

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
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 |
Principal Investigator: | Montasur Shaheen, MD | University of New Mexico |
Additional Information:
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 |