Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma
This study is ongoing, but not recruiting participants.
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: March 14, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The primary objective of this study is to determine the objective response rate of this drug combination of carboplatin, paclitaxel and temozolomide in the treatment of metastatic or recurrent melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma |
Drug: paclitaxel, carboplatin, temozolomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II 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:
- To determine the objective response rate for the combination of carboplatin, paclitaxel and temozolomide in the treatment of metastatic or recurrent melanoma. [ Time Frame: 6months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine median overall survival and median time to progression in the same population [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- To determine safety profile and major adverse events for this combination. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: paclitaxel, carboplatin, temozolomide
Carboplatin at an AUC of 5 on D1, paclitaxel at 175 mg/m2 on D1, temozolomide at 125 mg/m2 D2-D6 on a 28 day cycle.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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 and SGOT or SGPT < 2 times the upper limit of normal, and adequate renal function as defined by a serum creatinine ≤ 1.5 upper limit of normal
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01009515
Locations
| United States, New Mexico | |
| University of New Mexico Cancer Center | |
| Albuquerque, New Mexico, United States, 87106 | |
| The Cancer Center at Presbyterian | |
| Albuquerque, New Mexico, United States, 87110 | |
| Hematology Oncology Associates | |
| Albuquerque, New Mexico, United States, 87106 | |
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
| Principal Investigator: | Montasur Shaheen, MD | University of New Mexico |
More Information
No publications provided
| Responsible Party: | New Mexico Cancer Care Alliance |
| ClinicalTrials.gov Identifier: | NCT01009515 History of Changes |
| Other Study ID Numbers: | INST 0903, NCI-2011-01939 |
| Study First Received: | October 14, 2009 |
| Last Updated: | March 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New Mexico Cancer Care Alliance:
|
metastatic 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 Temozolomide Dacarbazine Carboplatin |
Paclitaxel Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013