Clinical trial NCT01009515: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Melanoma
Keywords: metastatic
melanoma
skin cancer
paclitaxel
carboplatin
temozolomide
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
First posted: 2009-11-06
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 6 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years
measure: Safety Profile
timeFrame: Up to 30 days after last on-study treatment, for up to 2 years
measure: Time to Progression
timeFrame: 2 years
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Hematology Oncology Associates
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Albuquerque
country: United States
facility: The Cancer Center at Presbyterian
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Montasur Shaheen, MD
role: PRINCIPAL_INVESTIGATOR
References: