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Phase 2 Study of Intravenous Administration of a Wild-Type Reovirus (REOLYSIN®) in Combination With Paclitaxel and Carboplatin in Patients With Platinum-Refractory Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck.

Phase 2
18 Years
Open (Enrolling)
Carcinoma, Squamous Cell of the Head and Neck

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Trial Information

Phase 2 Study of Intravenous Administration of a Wild-Type Reovirus (REOLYSIN®) in Combination With Paclitaxel and Carboplatin in Patients With Platinum-Refractory Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck.

Squamous cell carcinoma of the head and neck is the sixth most common cancer in the world.
More than 50% of patients diagnosed with advanced regional disease will relapse locally or
at distant sites. Initial therapeutic options include irradiation, surgery and
chemotherapy. The most commonly used agents are cisplatin and carboplatin, generally in
combination with 5-FU or a taxane. Erbitux has recently been approved for use in first-line
with radiation and in second-line as monotherapy. Only about a third of the patients will
respond to first-line platinum-based therapy and the median overall survival is 6-9 months.

Preliminary assessment of a Phase 1 study being conducted in the UK investigating the
combination of REOLYSIN®, carboplatin and paclitaxel suggested that patients with head and
neck carcinomas may represent a group of patients in whom this treatment combination is

This Phase 2 study is designed to characterize the efficacy and safety of REOLYSIN® given
intravenously in combination with paclitaxel and carboplatin every 3 weeks in patients with
squamous cell carcinoma of the head and neck.

Response is a primary endpoint of this trial. Patients will be clinically evaluated after
each course of treatment and radiologically every other cycle. A complete or partial
response must be confirmed at least 4 weeks after the first assessment that documents such a
response and every two cycles thereafter.

The safety of the paclitaxel, carboplatin and REOLYSIN® combination will be assessed by the
evaluation of the type, frequency and severity of adverse events, changes in clinical
laboratory tests, immunogenicity and physical examination.

Patients may continue to receive therapy under this protocol, provided they have not
experienced either progressive disease or unacceptable drug-related toxicity that does not
respond to either supportive care or dose reduction.

Inclusion Criteria:

- have platinum-refractory metastatic and/or recurrent histologically confirmed stage
III/IV squamous cell carcinoma of the head and neck (oral cavity, larynx or pharynx)
with no secondary cancers

- have evidence of measurable disease

- have documented progressive disease (PD) on or within 190 days following the
completion of treatment of cisplatin-based or carboplatin-based chemotherapy in a
recurrent or metastatic setting and if treatment with cetuximab was considered
indicated for the patient, documented PD(on or within 190 days of treatment)

- have no continuing acute toxic effect of any prior radiotherapy, chemotherapy or
surgical procedures

- have received no chemotherapy, radiotherapy, immunotherapy or hormonotherapy within
28 days

- have ECOG performance score of ≤2

- have life expectancy of at least 3 months

- absolute neutrophils ≥ 1.5 x10^9/L; platelets ≥100 x10^9; hemoglobin ≥9.0 g/dL; serum
creatinine ≤1.5 xULN; bilirubin ≤1.5 x ULN; AST/ALT ≤2.5xULN

- negative pregnancy test for females of childbearing potential

Exclusion Criteria:

- have known brain metastasis

- have known bone metastasis

- be on immunosuppressive therapy; have known HIV infection or active hepatitis B or C

- be a pregnant or breast-feeding woman

- have clinically significant cardiac disease

- have dementia or altered mental status that would prohibit informed consent

- have any other severe, acute or chronic medical or psychiatric condition or
laboratory abnormality that may increase the risk associated with study participation
or study drug administration or may interfere with the interpretation of study
results and, in the judgement of the Principal Investigator, would make the patient
inappropriate for this study

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population

Outcome Time Frame:

For PR or CR, changes in tumor measurements must be confirmed 4 weeks after the criteria for response are first met.

Safety Issue:


Principal Investigator

Monica Mita, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Therapy and Research Center at UTHSCSA


United States: Food and Drug Administration

Study ID:

REO 015



Start Date:

August 2008

Completion Date:

January 2012

Related Keywords:

  • Carcinoma, Squamous Cell of the Head and Neck
  • carcinoma
  • squamous cell
  • head
  • neck
  • chemotherapy
  • Carboplatin
  • Paclitaxel
  • Carcinoma
  • Carcinoma, Squamous Cell



Montefiore Medical CenterBronx, New York  10467-2490
Cancer Therapy and Research Center at UTHSCSASan Antonio, Texas  78229