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Phase II Trial of Irinotecan Plus Cisplatin in Patients With Recurrent or Metastatic Squamous Carcinoma of the Head and Neck


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Phase II Trial of Irinotecan Plus Cisplatin in Patients With Recurrent or Metastatic Squamous Carcinoma of the Head and Neck


OBJECTIVES:

- Evaluate the efficacy of irinotecan hydrochloride and cisplatin in patients with
local-regionally recurrent or metastatic squamous cell carcinoma of the head and neck.

- Evaluate the toxicity of irinotecan hydrochloride and cisplatin in these patients.

- Determine the palliative effect of irinotecan hydrochloride and cisplatin on head and
neck cancer symptoms using the Vanderbilt Cancer Center (VICC) Head and Neck Cancer
Symptom Survey.

OUTLINE: Patients receive irinotecan hydrochloride IV over 60 minutes and cisplatin IV on
days 1, 8, 22, and 29. Treatment repeats every 6 weeks for up to 6 courses in the absence of
disease progression or unacceptable toxicity.

Patients complete the Vanderbilt Cancer Center (VICC) Head and Neck Cancer Symptom Survey at
baseline, before each course, at the completion of study therapy, and then at each follow-up
visit.

After completion of study therapy, patients are followed every 6 weeks for 1 year and then
every 3 months thereafter.


Inclusion Criteria:



- Histologically confirmed squamous cell carcinoma of the head and neck that is
considered incurable with surgery or radiotherapy

- Meets one of the following criteria:

- Previously untreated disease

- Newly diagnosed disease with distant metastases

- Recurrent or persistent disease

- Local-regional recurrence/persistence or distant metastases after initial
treatment with surgery or radiotherapy

- No locally advanced unresectable disease that was not previously
treated with radiotherapy

- Bidimensionally measurable disease

- If the only measurable disease is within the radiotherapy port, there must be
biopsy-proven recurrence ≥ 8 weeks after the completion of radiotherapy

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy ≥ 12 weeks

- Creatinine clearance ≥ 50 mL/min

- SGOT ≤ 3 times upper limit of normal

- Serum bilirubin < 1.5 mg/dL

- Granulocytes ≥ 1,500/mm ^3

- Platelet count > 100,000/mm^3

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No significant detectable infection

- No co-morbid disease unless under adequate control

- No other cancer within the past 3 years except basal cell or squamous cell skin
cancer or early-stage prostate cancer

Exclusion Criteria:

-Pregnant or lactating women

Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from any prior major surgery

- No prior chemotherapy for recurrent or metastatic disease

- Patients who completed neoadjuvant, concurrent, or adjuvant chemotherapy ≥ 3
months prior to recurrence will be considered chemotherapy-naive

- Patients who completed neoadjuvant, concurrent, or adjuvant chemotherapy < 3
months prior to recurrence will be considered chemotherapy failures

- No prior therapy with topotecan or irinotecan hydrochloride

- At least 4 weeks since prior biologic therapy (e.g., interleukin-2, interferon,
megestrol acetate)

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient Response

Outcome Description:

Number of patients in each response category according to RECIST criteria: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.

Outcome Time Frame:

6 weeks after last chemotherapy treatment

Safety Issue:

No

Principal Investigator

Barbara A. Murphy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

VICC HN 0164

NCT ID:

NCT00639769

Start Date:

February 2002

Completion Date:

July 2008

Related Keywords:

  • Head and Neck Cancer
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV verrucous carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent verrucous carcinoma of the larynx
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent verrucous carcinoma of the oral cavity
  • stage IV verrucous carcinoma of the oral cavity
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • recurrent metastatic squamous neck cancer with occult primary
  • untreated metastatic squamous neck cancer with occult primary
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent salivary gland cancer
  • salivary gland squamous cell carcinoma
  • stage IV salivary gland cancer
  • Head and Neck Neoplasms

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Center for Biomedical ResearchKnoxville, Tennessee  37909
Jackson-Madison County HospitalJackson, Tennessee  38301
Meharry Medical CollegeNashville, Tennessee  37208-3599
Erlanger Health SystemChattanooga, Tennessee  37403
East Tennessee State UniversityJohnson City, Tennessee  37614-0054
Central Georgia Hematology Oncology Associates, P.C.Macon, Georgia  
VA Tennessee Valley Healthcare CenterNashville, Tennessee