search
Back to results

Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

Primary Purpose

Melanoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Paclitaxel, carboplatin, temozolomide
Sponsored by
New Mexico Cancer Care Alliance
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring metastatic, melanoma, skin cancer, paclitaxel, carboplatin, temozolomide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hematology Oncology Associates
  • University of New Mexico Cancer Center
  • The Cancer Center at Presbyterian

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemotherapy Combination

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival
The time from treatment initiation to death by any cause.
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.
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.

Full Information

First Posted
October 14, 2009
Last Updated
September 15, 2017
Sponsor
New Mexico Cancer Care Alliance
search

1. Study Identification

Unique Protocol Identification Number
NCT01009515
Brief Title
Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma
Official Title
Phase II Trial of Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
Low accrual; target accrual not met
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New Mexico Cancer Care Alliance

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
metastatic, melanoma, skin cancer, paclitaxel, carboplatin, temozolomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy Combination
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel, carboplatin, temozolomide
Intervention Description
Combination chemotherapy was administered for up to 6 cycles
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
The time from treatment initiation to death by any cause.
Time Frame
2 years
Title
Safety Profile
Description
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 Frame
Up to 30 days after last on-study treatment, for up to 2 years
Title
Time to Progression
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Montasur Shaheen, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hematology Oncology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
The Cancer Center at Presbyterian
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87110
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.cancer.unm.edu
Description
University of New Mexico Cancer Center
URL
http://www.nmcca.org
Description
New Mexico Cancer Care Alliance

Learn more about this trial

Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

We'll reach out to this number within 24 hrs