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Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma
This study has been terminated.
(Low accrual; target accrual not met)
Sponsor:
New Mexico Cancer Care Alliance
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT01009515
First received: October 14, 2009
Last updated: October 5, 2015
Last verified: October 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Melanoma | Drug: Paclitaxel, carboplatin, temozolomide | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma |
Resource links provided by NLM:
Further study details as provided by New Mexico Cancer Care Alliance:
Primary Outcome Measures:
- 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:
- 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.
| Enrollment: | 19 |
| Study Start Date: | August 2009 |
| Study Completion Date: | June 2015 |
| Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01009515
Please refer to this study by its ClinicalTrials.gov identifier: 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
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 ) |
| Study First Received: | October 14, 2009 |
| Results First Received: | August 14, 2015 |
| Last Updated: | October 5, 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 |
ClinicalTrials.gov processed this record on July 27, 2017