Taxotere/Temodar/Cisplatin Study in Melanoma Patients

NCT00527761 | Completed Phase 1

• 1 other identifier: 2003-1037
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: 1\. To determine the maximum tolerated dose of chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in patients with metastatic melanoma. Secondary Objectives:

1. 1.To determine the toxicity of chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in patients with metastatic melanoma
2. 2.To determine the response rate of induction chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in patients with metastatic melanoma.

Conditions

Metastatic Melanoma

Keywords

Metastatic Melanoma; Temozolomide; Temodar; Taxotere; Cisplatin; TTC

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  4 week cycles

Study Arms (1)

Temozolomide, Docetaxel + Cisplatin

EXPERIMENTAL

Drug: Cisplatin; Drug: Docetaxel; Drug: Temodar

Interventions

Cisplatin DRUG

20 mg in 500 ml of normal saline by vein over 60 minutes daily for 4 days starting on day 1 of chemotherapy.

Also known as: Platinol-AQ, Platinol, CDDP

Temozolomide, Docetaxel + Cisplatin

Docetaxel DRUG

Starting dose 20 mg by vein over 1 hour, once a week, for three weeks (on Days 1, 8, and 15).

Also known as: Taxotere

Temozolomide, Docetaxel + Cisplatin

Temodar DRUG

150 mg by mouth (PO) on Days 1 - 5.

Also known as: Temozolomide

Temozolomide, Docetaxel + Cisplatin

Eligibility Criteria

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

You may qualify if:

• Patients 18 or older with histologically documented diagnosis of advanced/inoperable melanoma are eligible.
• Patients must have measurable metastatic melanoma lesion(s), and at least 1 lesion must be greater then or equal 10 mm in a greatest diameter by spiral CT scan (or greater then or equal to 20 mm by a conventional non-spiral CT scan) to assess response. Cutaneous lesions may be 10 mm or larger in a greatest diameter.
• Patients with less than or equal to grade 1 peripheral neuropathy at the time of enrollment.
• Patients with controlled, asymptomatic brain metastases will be eligible. There should not be any evidence of progression in the brain metastases for at least 3 months after the complete surgical resection/stereotactic radiosurgery and/or a whole brain radiation therapy. Patients who are taking steroidal or anticonvulsant drug(s) for brain metastasis at the time of registration will not be eligible.
• Zubrod performance status of 0-2.
• ANC greater than or equal to 1,500/mm3 and a platelet count greater than or equal to 100,000/mm3.
• Serum creatinine less than or equal to 1.5 mg/dl
• Serum bilirubin level of less than or equal to 1.0 mg/dl (or up to institutional upper limit of normal (ULN))
• Serum transaminase (ALT and AST) less than or equal to 125 IU/l (or up to 2.5 x institutional ULN) if alkaline phosphatase is less than or equal to 130 IU/l (or institutional ULN), or alkaline phosphatase less than or equal to 500 IU/l (or up to 4 x ULN) if transaminases are less than or equal to 50 IU/l (or institutional ULN).
• No evidence of significant cardiac or pulmonary dysfunction.
• Patient must have a hemoglobin greater than or equal to 9 gm/dl (this may be achieved by transfusion if needed) obtained within 14 days prior to registration. If a patient receives PRBC transfusion to achieve a hemoglobin level of greater than or equal to 9 gm/dl, the hemoglobin level needs to be stable (no drop by more than 1 gm/dl from the post-transfusion hemoglobin level) for at least 1 week.
• Women of childbearing potential must have a negative pregnancy test and may not be breastfeeding.
• Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
• All patients must be informed of the investigational nature of this study and must sign and give written informed consent for treatment and in accordance with institutional and federal guidelines.

You may not qualify if:

• A prior exposure to all 3 drugs: taxanes, Temodar and platinum.
• A history of severe hypersensitivity reaction to drugs formulated with polysorbate 80.
• Any anti-cancer therapy within 28 days prior to enrollment.
• If a target lesion has been previously embolized, perfused or irradiated, there must be objective evidence of progression before start of therapy to be considered for response assessment.
• Uncontrolled brain metastases. Patient who is symptomatic from brain metastases or who takes steroidal or anticonvulsant drug for the management of brain metastases will be ineligible. Central nervous system involvement by melanoma either as spinal cord compression or leptomeningeal disease will also be excluded.
• Patients with significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricle function (EF less than 55%) on account of any organic disease such as hypertension or valvular heart disease or serious uncontrolled cardiac arrhythmias despite therapy.
• Patients with significant impairment of pulmonary function on account of chronic bronchitis or chronic obstructive pulmonary disease (COPD) which has resulted in impairment of vital capacity or FEV1 to less than 75% of predicted normal values.
• Symptomatic effusions on account of pleural, pericardial or peritoneal metastasis of melanoma.
• No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, surgically treated Stage I or II cancer from which the patient is currently in complete remission (at least for 5 years), or any other cancer from which the patient has been disease-free for 5 years.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Aventis Pharmaceuticals: collaborator

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Melanoma

Interventions

Cisplatin; Docetaxel; Temozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Dacarbazine; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kevin B. Kim, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2007
• First Posted: September 11, 2007
• Study Start: August 1, 2004
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

US (1)