Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

Melanoma Clinical Trial

Official title:

Phase II Trial of Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01009515
• Other study ID #: INST 0903
• Secondary ID: NCI-2011-01939
• Status: Terminated
• Phase: Phase 2
• First received: October 14, 2009
• Last updated: September 15, 2017
• Start date: August 2009
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: New Mexico Cancer Care Alliance
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: June 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• Paclitaxel, carboplatin, temozolomide
Combination chemotherapy was administered for up to 6 cycles

Locations

Country	Name	City	State
United States	Hematology Oncology Associates	Albuquerque	New Mexico
United States	The Cancer Center at Presbyterian	Albuquerque	New Mexico
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
New Mexico Cancer Care Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	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.	6 months
Secondary	Overall Survival	The time from treatment initiation to death by any cause.	2 years
Secondary	Safety Profile	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.	Up to 30 days after last on-study treatment, for up to 2 years
Secondary	Time to Progression	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.	2 years

External Links

•   New Mexico Cancer Care Alliance
•   University of New Mexico Cancer Center