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Head and Neck CancerPhase 3NCT00002659

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

A Phase 3 study testing cisplatin-e therapeutic implant in people with Head and Neck Cancer, run by Matrix Pharmaceutical at 28 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
cisplatin-e therapeutic implant
How many people
120 participants
Where
28 sitesin 2 countries
Study dates
May 1995to not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

28 sites in 2 countries.

28 sites in 2 countries

United States26 sites

  • University of New Mexico Cancer Research & Treatment Center

    Albuquerque, New Mexico, 87131

  • Comprehensive Cancer Center at JFK Medical Center

    Atlantis, Florida, 33462

  • Southwest Regional Cancer Center

    Austin, Texas, 78705

  • Veterans Affairs Medical Center - Baltimore

    Baltimore, Maryland, 21218

  • Palmetto Richland Memorial Hospital

    Columbia, South Carolina, 29203

  • University of Texas Southwestern Medical School

    Dallas, Texas, 75235-9032

  • Evanston Northwestern Health Care

    Evanston, Illinois, 60201

  • Capitol Comprehensive Cancer Care Clinic

    Jefferson City, Missouri, 65109

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • University of Kentucky College of Medicine

    Lexington, Kentucky, 40536-0084

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • Boston Cancer Group

    Memphis, Tennessee, 38119

  • Sylvester Cancer Center, University of Miami

    Miami, Florida, 33136

  • Department of Otolaryngology

    Milwaukee, Wisconsin, 53226

  • Louisiana State University Medical Center - New Orleans

    New Orleans, Louisiana, 70112

  • Methodist Cancer Center - Omaha

    Omaha, Nebraska, 68114

  • Creighton University Cancer Center

    Omaha, Nebraska, 68131-2197

  • Veterans Affairs Medical Center - Palo Alto

    Palo Alto, California, 94304

  • Oregon Cancer Center at Oregon Health Sciences University

    Portland, Oregon, 97201-3098

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California, 94115-0128

  • Louisiana State University Hospital - Shreveport

    Shreveport, Louisiana, 71130-3932

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305-5408

  • Veterans Affairs Medical Center - Tucson

    Tucson, Arizona, 85723

  • Arizona Cancer Center

    Tucson, Arizona, 85724

Other trials in United States

Canada2 sites

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Ville Marie Oncology Center

    Montreal, Quebec, H3G 1L5

Other trials in Canada

About this study

Official title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFECT OF CISPLATIN/EPINEPHRINE INJECTABLE GEL (PRODUCT MPI 5010) WHEN ADMINISTERED INTRATUMORALLY FOR ACHIEVEMENT OF TREATMENT GOALS IN RECURRENT OR REFRACTORY SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK

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.

Read the 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.

Being tested
cisplatin-e therapeutic implant
Keywords
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
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cisplatin-e therapeutic implantDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2004 (estimated)
  2. Study startMay 1995

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002659
Sponsor's protocol ID
CDR0000064225
Other IDs
MP-414-94-2, NCI-V95-0676
Status last verified
May 2007
First submitted
1 Nov 1999
Last updated
19 Dec 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin-e therapeutic implant in people with Head and Neck Cancer, run by Matrix Pharmaceutical at 28 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002659.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.

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