NCT00242762

Brief Summary

The primary objective of the study is to evaluate the activity of the combination ZD1839, docetaxel and cisplatin in subjects with recurrent and/or metastatic head and neck cancer by estimating the objective response rate (complete response \[CR\] and partial response \[PR\]) at study closure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Jul 2003

Shorter than P25 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

January 27, 2011

Status Verified

January 1, 2011

Enrollment Period

2.7 years

First QC Date

October 20, 2005

Last Update Submit

January 25, 2011

Conditions

Head and Neck Cancer

Keywords

Head and Neck NeoplasmsCancer of Head and NeckHead and Neck CancerHead CancerNeck Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective tumour response (CR and PR) at study closure based on the Response Evaluation Criteria in Solid Tumours (RECIST)

Secondary Outcomes (4)

  • PFS

  • Overall survival

  • Incidence of DLT during the first cycle of study treatment

  • Nature, incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Interventions

ZD1839 (IRESSA™)DRUG
DocetaxelDRUG
CisplatinDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, aged 18 and 70 years, inclusive
  • Histologically- or cytologically-confirmed recurrent and/or metastatic SCCHN
  • Primary tumour site of oral cavity, oropharynx, hypopharynx or larynx
  • At least one uni-dimensionally measurable lesion according to the RECIST
  • World Health Organisation (WHO) performance status (PS) of 0 or 1
  • No previous chemotherapy for recurrent or metastatic disease
  • Before subject registration a quality of life questionnaire should be completed

You may not qualify if:

  • Previous chemotherapy for recurrent or metastatic disease
  • Less than 6 months since prior induction or adjuvant platinum and/or taxanes chemotherapy
  • Known severe hypersensitivity to ZD1839 or any of the excipients of this product
  • Known, severe hypersensitivity to docetaxel or cisplatin or any of the excipients of these products, or to other drugs formulated with polysorbate 80
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  • Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy (except alopecia)
  • Absolute neutrophil count (ANC) less than 1.5 x109/litre (L), platelets less than 100 x 109/L or haemoglobin less than 10 g/dl
  • Serum bilirubin greater than the upper limit of the reference range (ULRR)
  • Serum creatinine greater than 1.5 mg/dl despite adequate rehydration
  • Creatinine clearance less than 60 ml/min assessed in over a 24 hour urine collection
  • As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 times the ULRR or alkaline phosphatase (ALP) greater than 2.5 times the ULRR
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
  • Pregnancy or breast feeding (women of child-bearing potential)
  • Concomitant use of phenytoin, carbamazepine, rifampicin, or barbiturates, or St John's Wort
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Facility

Granada, Spain

Location

Research Facility

Madrid, Spain

Location

Research Facility

Murcia, Spain

Location

Research Site

Seville, Spain

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

GefitinibDocetaxelCisplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • AstraZeneca Spain Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 20, 2005

First Posted

October 21, 2005

Study Start

July 1, 2003

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

January 27, 2011

Record last verified: 2011-01

Locations

ES(4)