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Cisplatin Plus Epinephrine in Treating Patients With Recurrent or Refractory Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002659
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : August 31, 2004
Last Update Posted : December 19, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if treatment with cisplatin plus epinephrine is effective for head and neck cancer.

PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of cisplatin plus epinephrine in injectable gel form in treating patients who have recurrent or refractory head and neck cancer.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: cisplatin-e therapeutic implant Phase 3

Detailed Description:

OBJECTIVES: I. Compare the effect of intratumoral injection of a cisplatin/epinephrine gel (CDDP-e TI) to placebo gel for local control of recurrent or refractory squamous cell carcinoma of the head and neck. II. Assess achievement of a preselected (by the investigator) treatment goal for the most troublesome tumor in patients with recurrent or refractory squamous cell carcinoma of the head and neck following up to 6 weekly intratumoral treatments with CDDP-e TI vs. placebo gel. III. Compare the effect of CDDP-e TI to placebo gel on total local tumor volume per patient. IV. Evaluate the time to response and time to progression for the most troublesome tumor after local treatment with CDDP-e TI vs. placebo gel. V. Assess the improvement in or stabilization of quality of life in these patients as measured by the FACT-H&N questionnaire. VI. Compare the histopathology of injected lesions that respond to local treatment.

OUTLINE: Randomized, double-blind study. Randomization weighted 2:1 in favor of Arm I. Arm I: Intratumoral Chemotherapy. Cisplatin (NSC-119875) and Epinephrine in a bovine collagen gel, MP 5010, CDDP-e TI. Arm II: Control. NS in a bovine collagen gel, PLCB.

PROJECTED ACCRUAL: Up to 120 evaluable patients will be studied to provide 80 evaluable patients on Arm I and 40 evaluable patients on Arm II.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : May 1995

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and neck that is recurrent or refractory following at least 1 course of therapy Primary or metastatic tumors involving skin, nodes (palpable and biopsy- proven), subcutaneous tissue, or muscle allowed No involvement of major artery or any visceral organ Measurable lesions accessible for direct intratumoral injection with no immediate risk of hemorrhage or embolization Most troublesome tumor (identified by the investigator) at least 0.5 cc and no greater than 20 cc Smaller tumors eligible for treatment but not for efficacy assessment An improvable primary treatment goal (palliative or preventive) for most troublesome tumor must be identified by the investigator prior to enrollment If multiple tumors qualify as most troublesome and share the primary physician-selected treatment goal, the largest tumor is selected Patient may also select a most troublesome tumor and 1 palliative treatment goal for that tumor (need not match the physician-selected tumor or goal) No fibrotic lesions (e.g., previously irradiated lesion with no subsequent disease progression) No tumors involving or threatening to invade the carotid or other major vessel

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100% Life expectancy: At least 6 months Hematopoietic: Absolute granulocyte count greater than 1,000/mm3 Platelet count greater than 75,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.5 times normal Cardiovascular: No NYHA class III/IV status No history of arrhythmia that would increase risk of treatment Other: No hypersensitivity to cisplatin, bovine collagen, epinephrine, or sulfites No significant history of extracranial carotid vascular disease from atherosclerosis, radiation therapy or previous carotid artery surgery No uncontrolled local infection at treatment sites No medical or psychiatric condition that would preclude informed consent No pregnant or nursing women Adequate contraception required of fertile patients

PRIOR CONCURRENT THERAPY: More than 28 days since any antineoplastic therapy or therapy with investigational agents Fully recovered from side effects of prior treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002659

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Sponsors and Collaborators
Matrix Pharmaceutical
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Study Chair: Mack H. Mabry, MD SUGEN

Layout table for additonal information Identifier: NCT00002659     History of Changes
Other Study ID Numbers: CDR0000064225
First Posted: August 31, 2004    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: May 2007
Keywords provided by National Cancer Institute (NCI):
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Epinephryl borate
Antineoplastic Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents