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NCT00639769 · REGISTRY CONDITION SEARCH

Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2012-09-14

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Patient Response

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outcome · POSTED

Number of Patients With Each Worst-grade Toxicity

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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)
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: cisplatin
    2. Drug: irinotecan hydrochloride
    label
    Therapeutic Intervention
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Therapeutic Intervention
    description
    Starting dose 30 mg/m2 Dose level -1 20 mg/m2
    name
    cisplatin
    other Names
    1. Platinol,Platinol-AQ,cisdamminedichloroplatinum(II),kCDDP,DDP,DACP,cisplatinum,platinum
    type
    DRUG
  2. arm Group Labels
    1. Therapeutic Intervention
    description
    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.
    name
    irinotecan hydrochloride
    other Names
    1. CPT-11
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
41
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. 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.
    measure
    Patient Response
    time Frame
    6 weeks after last chemotherapy treatment
secondary Outcomes
  1. description
    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
    measure
    Number of Patients With Each Worst-grade Toxicity
    time Frame
    6 weeks after last chemotherapy
Full study description
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.
Source references
references
  1. citation
    Gilbert J, Cmelak A, Shyr Y, Netterville J, Burkey BB, Sinard RJ, Yarbrough WG, Chung CH, Aulino JM, Murphy BA. Phase II trial of irinotecan plus cisplatin in patients with recurrent or metastatic squamous carcinoma of the head and neck. Cancer. 2008 Jul 1;113(1):186-92. doi: 10.1002/cncr.23545.
    pmid
    18484593
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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      query cond
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      query cond
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    Preserved source evidence · Not medical advice