Head and Neck Cancer
Conditions
Keywords
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
Brief summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: To determine if CPT-11 given together with cisplatin is effective in treating recurrent or metastatic head and neck cancer.
Detailed description
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.
Interventions
DRUGcisplatin
Starting dose 30 mg/m2 Dose level -1 20 mg/m2
DRUGirinotecan hydrochloride
50 mg/m2 IV over 60 minutes, plus Cisplatin 30mig/m2 IV, repeated weekly for two weeks. followed by a one-week rest. This 3-week schedule given two times to equal one 6-week cycle. Maximum of 6 cycles.
Sponsors
National Cancer Institute (NCI)
Vanderbilt-Ingram Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Response | 6 weeks after last chemotherapy treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Each Worst-grade Toxicity | 6 weeks after last chemotherapy | Number of patients with worst-grade toxicity response of each grade (grade 1 to 5) following NCI Common Toxicity Criteria, with grade 1=mild adverse event; 2=moderate adverse event; 3=severe and undesirable adverse event; 4=life-threatening or disabling adverse event; 5=death |
Countries
United States
Participant flow
Recruitment details
Recruitment period = 2/27/2002 through 5/9/2006
Pre-assignment details
A total of 41 people signed consent to take part in this study, of those, 1 was determined to be ineligible.
Participants by arm
| Arm | Count |
|---|---|
| Therapeutic Intervention Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2 | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Death | 2 |
| Overall Study | Disease progression | 26 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Therapeutic Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Age Continuous | 58 years STANDARD_DEVIATION 1 |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 27 / 40 |
Outcome results
Primary
Patient Response
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.
Time frame: 6 weeks after last chemotherapy treatment
Population: Analysis was per protocol (7 patients did not receive a full cycle of treatment, and 1 patient was censored for incomplete records)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Therapeutic Intervention | Patient Response | Partial Response | 11 participants |
| Therapeutic Intervention | Patient Response | Progressive Disease | 15 participants |
| Therapeutic Intervention | Patient Response | Stable Disease | 6 participants |
| Therapeutic Intervention | Patient Response | Complete response | 0 participants |
Secondary
Number of Patients With Each Worst-grade Toxicity
Number of patients with worst-grade toxicity response of each grade (grade 1 to 5) following NCI Common Toxicity Criteria, with grade 1=mild adverse event; 2=moderate adverse event; 3=severe and undesirable adverse event; 4=life-threatening or disabling adverse event; 5=death
Time frame: 6 weeks after last chemotherapy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Therapeutic Intervention | Number of Patients With Each Worst-grade Toxicity | No. of patients with worst-grade toxicity of 1 | 2 participants |
| Therapeutic Intervention | Number of Patients With Each Worst-grade Toxicity | No. of patients with worst-grade toxicity of 2 | 12 participants |
| Therapeutic Intervention | Number of Patients With Each Worst-grade Toxicity | No. of patients with worst-grade toxicity of 3 | 21 participants |
| Therapeutic Intervention | Number of Patients With Each Worst-grade Toxicity | No. of patients with worst-grade toxicity of 4 | 10 participants |
| Therapeutic Intervention | Number of Patients With Each Worst-grade Toxicity | No. of patients with worst-grade toxicity of 5 | 1 participants |