AzTrials
AzTrials

Nasopharyngeal CancerPhase 2NCT00603915

A Study of Gemcitabine and Cisplatin/Carboplatin Plus Erlotinib in Patients With Nasopharyngeal Cancer

A Phase 2 study testing Gemcitabine, Carboplatin/Cisplatin and erlotinib in people with Nasopharyngeal Cancer, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Cisplatin or Carboplatin will be given on day 1 every 21 days for 6 cycles; Gemcitabine will be given on day 1 and day 8 every 21 days for 6 cycles. Those patients that do not progress on GC after 6 cycles of chemotherapy will be started on erlotinib daily until disease progression. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nasopharyngeal Cancer
What is being tested?
Gemcitabine, Carboplatin/Cisplatin and erlotinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
Jun 2006to Apr 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • 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.)
Show all 26Show fewer
  • 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 occurred.
  • 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

Who cannot join

  • 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 participation.
  • 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;
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

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

Cisplatin or Carboplatin will be given on day 1 every 21 days for 6 cycles; Gemcitabine will be given on day 1 and day 8 every 21 days for 6 cycles. Those patients that do not progress on GC after 6 cycles of chemotherapy will be started on erlotinib daily until disease progression. A cycle of erlotinib will be 28 days. Patients who progress on GC will be offered erlotinib as well,in order to evaluate its activity as a single-agent in the second-line setting.

Patients previously treated with GC have reported a progression-free survival (PFS) of 9 months. We would anticipate an extension of PFS to 12 months in patients treated with GC followed by maintenance erlotinib. Furthermore, we hypothesize that patients who achieved benefit from GC therapy would have further response when treated with maintenance erlotinib, such that this strategy may increase the likelihood of attaining long-term survival.

Being tested
Gemcitabine, Carboplatin/Cisplatin, erlotinib
Keywords
gemcitabine, carboplatin, cisplatin, erlotinib, tarceva, nasopharyngeal
Medical subject headings
Nasopharyngeal Neoplasms

What participants receive

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

  • GemcitabineDrug

    1000mg/m^2 intravenous (IV) day 1 and day 8

  • Carboplatin/CisplatinDrug

    Area under curve (AUC)=5 (Carboplatin) or 70mg/m^2 (Cisplatin) intravenous (IV) day 1

  • erlotinibDrug

    150mg daily (post GC therapy)

Study groups in NCT00603915
Study groupRoleWhat they receive
GC Plus ErlotinibExperimentalEligible patients are treated with cisplatin/carboplatin and gemcitabine (GC) for 6 cycles of therapy followed by maintenance erlotinib. Those patients achieving SD or PR with chemotherapy will be started on maintenance erlotinib until disease progression. Those patients achieving CR with chemotherapy will be started on erlotinib for 6 cycles of treatment and those achieving CR on erlotinib will be treated with a maximum of 6 further cycles of erlotinib. Those patients with disease progression while on chemotherapy will be offered erlotinib 2 weeks following the last dose of chemotherapy until further disease progression.
Receives: Drug: Gemcitabine; Drug: Carboplatin/Cisplatin; Drug: erlotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival.

    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.

    Measured: 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.

Secondary outcomes (1)

  1. Number of Participants With the Responses Outlined

    Complete Response (CR): disappearance of all clinical and radiological evidence of tumour.

    Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD.

    Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

    Progressive Disease (PD): at least a 20% increase in the sum of LD of measured lesions taking as references the smallest sum LD recorded since the treatment started. Appearance of new lesions will also constitute progressive disease.

    Measured: Measured every 2 cycles until the participant is off treatment.

Timeline

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

  1. First posted29 Jan 2008 (estimated)
  2. Study startJun 2006
  3. Primary completionDec 2010
  4. Study completionApr 2011

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00603915
Sponsor's protocol ID
NPC-774
Other IDs
NPC-774
Status last verified
Feb 2019
First submitted
17 Jan 2008
Last updated
28 Feb 2019
Data monitoring committee
Yes

Publications

  • You B, Le Tourneau C, Chen EX, Wang L, Jarvi A, Bharadwaj RR, Kamel-Reid S, Perez-Ordonez B, Mann V, Siu LL. A Phase II trial of erlotinib as maintenance treatment after gemcitabine plus platinum-based chemotherapy in patients with recurrent and/or metastatic nasopharyngeal carcinoma. Am J Clin Oncol. 2012 Jun;35(3):255-60. doi: 10.1097/COC.0b013e31820dbdcc.

    PubMed 21358293

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine, Carboplatin/Cisplatin and erlotinib in people with Nasopharyngeal Cancer, run by University Health Network, Toronto at 1 site in Canada.

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

Who may be eligible to take part?

The sponsor lists 26 inclusion and 12 exclusion criteria. 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: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Progression Free Survival. (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00603915, which also lists 1 linked publication.

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 28 Feb 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in