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Phase II Trial of Gemcitabine and Cisplatin/Carboplatin (GC) Plus Erlotinib in Patients With Recurrent and/or Metastatic Nasopharyngeal Cancer

Phase 2
18 Years
Not Enrolling
Nasopharyngeal Cancer

Thank you

Trial Information

Phase II Trial of Gemcitabine and Cisplatin/Carboplatin (GC) Plus Erlotinib in Patients With Recurrent and/or Metastatic Nasopharyngeal Cancer

Inclusion Criteria:

- Patients must have histologically confirmed World Health Organization (WHO) type I
(keratinizing squamous cell carcinoma) or WHO type II a or b (differentiated
non-keratinizing carcinoma or undifferentiated carcinoma) NPC.

- Presence of clinically and/or radiologically documented disease. At least one site of
disease must be unidimensionally measurable as follows:

- X-ray, physical exam > 20 mm

- Spiral CT scan > 10 mm

- Non-spiral CT scan > 20 mm

- Investigations including chest x-ray or CT scan of chest, CT or MRI of head and neck
(for patients with locally advanced or locally recurrent disease) and other scans as
necessary to document all sites of study disease have been performed within 28 days
prior to randomization. (Exceptions will be made only for patients who have negative
examinations within 35 days prior to registration; exceptions for bone scans will be
made for negative examinations within 60 days prior to registration.)

- Age > 18 years.

- ECOG performance status of 0,1 or 2 (see Appendix II).

- Patients must have a life expectancy of at least 12 weeks.

- Previous Therapy:

- Chemotherapy: Advanced Disease: Patients may not have had prior therapy for
recurrent or metastatic disease.

- Curative Therapy: Patients may have had prior chemotherapy (including cisplatin/
carboplatin based regimens) in the neoadjuvant, concurrent and adjuvant setting
for locally advanced nasopharyngeal carcinoma provided that 4 weeks have elapsed
since treatment and any residual treatment related neuropathy or ototoxicity is
< grade 1 for cisplatin dosing on this trial. Patient with neuropathy or
ototoxicity > grade 2 will be dosed with carboplatin if otherwise eligible for
this trial.

- Radiation: Patients may have received prior radiotherapy provided that the last
fraction was given at least 4 weeks prior to registration and all toxicities
have resolved. If radiotherapy was delivered to the only site of measurable
disease, then progression must have been documented in that site after
completion of radiotherapy and prior to registration.

- Previous Surgery: Previous major surgery is permitted provided that it has been
at least 21 days prior to patient registration and that wound healing has

- Laboratory Requirements (must be done within 7 days prior to registration)

- Hematology:

- granulocytes (AGC) > 1.5 x 109/L

- platelets > 100 x 109/L

- Chemistry:

- AST < 2.5 x UNL

- ALT < 2.5 x UNL

- Creatinine clearance(*) : CrCl > 60mls/min for cisplatin or CrCl between 30
- 59ml/min for Carboplatin

(*) calculated

- Patient consent must be obtained according to local Institutional and/or University
Human Experimentation Committee requirements. The patient must sign the consent form
prior to randomization or registration.

- Patients must be accessible for treatment and follow up.

- Normal serum calcium

Exclusion Criteria:

- Patients with a history of other malignancies, except: adequately treated
non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other
solid tumours curatively treated with no evidence of disease for > 5 years.

- Patients with non-measurable disease only. (Please note that bone metastases are
considered non-measurable).

- Pregnant or lactating women. However, if the patient is of childbearing potential, a
urine β-HCG must be proved negative within 7 days prior to registration. Women of
child-bearing potential must agree to use adequate contraception (hormonal or barrier
method of birth control) prior to study entry and for the duration of study

- Patients with known brain metastases. (A head CT is not necessary to rule out brain
metastases, unless there is clinical suspicion of CNS involvement).

- Serious illness or medical condition, which would not permit the patient to be
managed according to the protocol including, but not limited to:

- History of significant neurologic or psychiatric disorder which would impair the
ability to obtain consent or limit compliance with study requirements;

- Active uncontrolled infection;

- Symptomatic congestive heart failure, unstable angina, cardiac arrhythmia.

- Prior anti-EGFR monoclonal antibody or tyrosine kinase inhibitors.

- Any inflammatory changes of the surface of the eye.

- Hypersensitivity to erlotinib (Tarceva) or to any of the excipients

- Concomitant requirement for medications classified as CYP3A4 inducer or inhibitor.
Inhibitors of CYP3A4 are prohibited beginning at least seven (7) days prior to the
administration of the first dose of study medication and for the duration of the
study. Inducers of CYP3A4 are prohibited beginning at least fourteen (14) days prior
to the administration of the first dose of study medication and for the duration of
the study.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival.

Outcome Description:

From randomization to the first documented disease progression or death from any cause, whichever came first, assessed until all participants randomized to the study have progressed for died.

Outcome Time Frame:

From the on-study date until the date of first documented progression or date of death from any cause any cause until all participants have progressed or died.

Safety Issue:


Principal Investigator

Lillian Siu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto


Canada: Health Canada

Study ID:




Start Date:

June 2006

Completion Date:

April 2011

Related Keywords:

  • Nasopharyngeal Cancer
  • gemcitabine
  • carboplatin
  • cisplatin
  • erlotinib
  • tarceva
  • nasopharyngeal
  • Nasopharyngeal Neoplasms