Taxotere/Temodar/Cisplatin Study in Melanoma Patients

This study has been completed.
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00527761
First received: September 10, 2007
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

Primary Objective:

1. To determine the maximum tolerated dose of chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in patients with metastatic melanoma.

Secondary Objectives:

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

Condition Intervention Phase
Metastatic Melanoma
Drug: Cisplatin
Drug: Docetaxel
Drug: Temodar
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of TTC (Taxotere/Temodar/Cisplatin) in Metastatic Melanoma Patients

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: 4 week cycles ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: August 2004
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Temozolomide, Docetaxel + Cisplatin Drug: Cisplatin
20 mg in 500 ml of normal saline by vein over 60 minutes daily for 4 days starting on day 1 of chemotherapy.
Other Names:
  • Platinol-AQ
  • Platinol
  • CDDP
Drug: Docetaxel
Starting dose 20 mg by vein over 1 hour, once a week, for three weeks (on Days 1, 8, and 15).
Other Name: Taxotere
Drug: Temodar
150 mg by mouth (PO) on Days 1 - 5.
Other Name: Temozolomide

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients 18 or older with histologically documented diagnosis of advanced/inoperable melanoma are eligible.
  2. 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.
  3. Patients with less than or equal to grade 1 peripheral neuropathy at the time of enrollment.
  4. 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.
  5. Zubrod performance status of 0-2.
  6. ANC greater than or equal to 1,500/mm3 and a platelet count greater than or equal to 100,000/mm3.
  7. Serum creatinine less than or equal to 1.5 mg/dl
  8. Serum bilirubin level of less than or equal to 1.0 mg/dl (or up to institutional upper limit of normal (ULN))
  9. 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).
  10. No evidence of significant cardiac or pulmonary dysfunction.
  11. 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.
  12. Women of childbearing potential must have a negative pregnancy test and may not be breastfeeding.
  13. 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.
  14. 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.

Exclusion Criteria:

  1. A prior exposure to all 3 drugs: taxanes, Temodar and platinum.
  2. A history of severe hypersensitivity reaction to drugs formulated with polysorbate 80.
  3. Any anti-cancer therapy within 28 days prior to enrollment.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. Symptomatic effusions on account of pleural, pericardial or peritoneal metastasis of melanoma.
  9. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00527761

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Aventis Pharmaceuticals
Investigators
Principal Investigator: Kevin B. Kim, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00527761     History of Changes
Other Study ID Numbers: 2003-1037
Study First Received: September 10, 2007
Last Updated: July 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Metastatic Melanoma
Temozolomide
Temodar
Taxotere
Cisplatin
TTC

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Temozolomide
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014