Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

NCT01009515 | Terminated Phase 2 Results DMC

• 2 other identifiers: INST 0903NCI-2011-01939
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

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.

Conditions

Melanoma

Keywords

metastatic; melanoma; skin cancer; paclitaxel; carboplatin; temozolomide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall Survival

  2 years

• Safety Profile

  Up to 30 days after last on-study treatment, for up to 2 years

• Time to Progression

  2 years

Study Arms (1)

Chemotherapy Combination

EXPERIMENTAL

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.

Drug: Paclitaxel, carboplatin, temozolomide

Interventions

Paclitaxel, carboplatin, temozolomide DRUG

Combination chemotherapy was administered for up to 6 cycles

Chemotherapy Combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (3)

Hematology Oncology Associates

Albuquerque, New Mexico, 87106, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

The Cancer Center at Presbyterian

Albuquerque, New Mexico, 87110, United States

Location

Related Links

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

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis; Skin Neoplasms

Interventions

Paclitaxel; Carboplatin; Temozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Dacarbazine; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Montaser Shaheen, MD, PhD
• Organization: University of New Mexico

MoShaheen@salud.unm.edu

505-925-0404

Study Officials

• Montasur Shaheen, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: November 6, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: June 1, 2015
• Last Updated: October 18, 2017
• Results First Posted: November 3, 2015

Record last verified: 2015-10

Locations

US (3)