Gemcitabine in Treating Patients With Recurrent or Metastatic Adenoid Cystic Cancer of the Head and Neck

Head and Neck Cancer Clinical Trial

Official title:

Phase II Study On Gemcitabine In Recurrent Or Metastatic Adenoid Cystic Carcinoma Of The Head And Neck

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00017498
• Other study ID #: EORTC-24982
• Secondary ID: EORTC-24982
• Status: Completed
• Phase: Phase 2
• First received: June 6, 2001
• Last updated: September 20, 2012
• Start date: February 2001

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have recurrent or metastatic adenoid cystic cancer of the head and neck.

Description:

OBJECTIVES:

• Assess the therapeutic activity of gemcitabine, in terms of objective response and duration of response, in patients with recurrent or metastatic adenoid cystic carcinoma of the head and neck.

• Determine the acute toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 12 weeks until disease progression and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 16-29 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic or recurrent adenoid cystic carcinoma of the head and neck for which no curative options exist

• Symptomatic and/or progressive disease

• At least 1 unidimensionally measurable lesion

• At least 20 mm by conventional techniques OR

• At least 10 mm by spiral CT scan

• No bone metastases as only lesion

• Prior radiotherapy to only target lesion allowed if it has progressed or reappeared after radiotherapy

• No CNS metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,500/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin no greater than 1.25 times upper limit of normal (ULN) (2.5 times ULN if liver metastases present)

• AST or ALT less than 3 times ULN (5 times ULN if liver metastases present)

Renal:

• Creatinine no greater than 1.7 mg/dL

Other:

• No uncontrolled infection

• No concurrent serious systemic disorders that would preclude study

• No other prior or concurrent malignancy except:

• Adequately treated carcinoma in situ of the cervix

• Basal cell or squamous cell skin cancer

• Any malignancy that occurred more than 5 years ago with no symptoms or signs of recurrence (except malignant melanoma, hypernephroma, or breast carcinoma)

• No psychological, familial, sociological, or geographical condition that would preclude study compliance

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent immunotherapy

Chemotherapy:

• No prior chemotherapy

• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent anti-estrogen therapy

• Concurrent steroid replacement or steroids as an antiemetic allowed

Radiotherapy:

• See Disease Characteristics

• At least 3 months since prior radiotherapy except for palliative radiotherapy to bone lesions

• No concurrent radiotherapy

Surgery:

• Not specified

Other:

• At least 1 month since prior investigational agents

• No other concurrent experimental medications

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Adenoid Cystic
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Brussels
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	U.Z. Gasthuisberg	Leuven
Italy	Ospedale Santa Croce	Cuneo
Italy	Istituto Nazionale per lo Studio e la Cura dei Tumori	Milan
Netherlands	Vrije Universiteit Medisch Centrum	Amsterdam
Netherlands	University Medical Center Nijmegen	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Italy,  Netherlands, 

References & Publications (1)

van Herpen CM, Locati LD, Buter J, Thomas J, Bogaerts J, Lacombe D, de Mulder P, Awada A, Licitra L, Bernier J, Vermorken JB. Phase II study on gemcitabine in recurrent and/or metastatic adenoid cystic carcinoma of the head and neck (EORTC 24982). Eur J C — View Citation