Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

This study has been terminated.
(Low accrual; target accrual not met)
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT01009515
First received: October 14, 2009
Last updated: June 17, 2015
Last verified: June 2015

October 14, 2009
June 17, 2015
August 2009
September 2013   (final data collection date for primary outcome measure)
Objective Response Rate (ORR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1). ORR is the sum of the percentages of patients achieving complete and partial responses
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 ]
Complete list of historical versions of study NCT01009515 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The time from treatment initiation to death by any cause
  • Safety profile and major adverse events for this combination [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    All toxicities encountered during the study will be graded according to the NCI CTCAE (Version 3.0).
  • Time to Progression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To determine median overall survival and median time to progression in the same population [ Time Frame: Until disease progression ] [ 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 ]
Not Provided
Not Provided
 
Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma
Phase II of Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma
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.
Other Name: paclitaxel, carboplatin, temozolomide
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.
Intervention: Drug: paclitaxel, carboplatin, temozolomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
June 2015
September 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01009515
INST 0903, NCI-2011-01939
No
New Mexico Cancer Care Alliance
New Mexico Cancer Care Alliance
Not Provided
Principal Investigator: Montasur Shaheen, MD University of New Mexico
New Mexico Cancer Care Alliance
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP