NCT00248560 · REGISTRY CONDITION SEARCH

Gemcitabine and Docetaxel in Treating Patients With Persistent, 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: 2019-03-05

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, 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: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with persistent, 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

Response (Complete Response [CR] + Partial Response [PR])

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outcome · POSTED

Response Duration

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outcome · POSTED

Survival

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outcome · POSTED

Toxicity as Measured by Number and Grade of Adverse Events

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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: DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the head and neck * Metastatic, persistent, or recurrent disease * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * Must have had definitive surgery and/or radiation therapy AND received at least 1, but no more than 2, chemotherapy regimens, either given as primary therapy or adjuvant therapy before or after surgery and/or radiotherapy * No active or prior CNS metastasis PATIENT CHARACTERISTICS: Age * 18 and over Performance status * SWOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Granulocyte count \> 1,500/mm\^3 * Hemoglobin ≥ 8 g/dL * Platelet count \> 100,000/mm\^3 Hepatic * Bilirubin normal * Meets 1 of the following criteria: * Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN) * AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN * AP ≤ 5 times ULN AND AST or ALT normal Renal * Creatinine \< 1.5 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment * No peripheral neuropathy ≥ grade 2 * No active infection requiring systemic therapy * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or any other site * No history of severe hypersensitivity reaction to study drugs or other drugs formulated with polysorbate 80 * No other serious condition that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * No prior taxane or gemcitabine * At least 4 weeks since prior chemotherapy and recovered Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered Surgery * See Disease Characteristics Other * No other concurrent therapy for this disease
healthy Volunteers: false
maximum Age: 120 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
intervention Names
Drug: docetaxel
Drug: Gemcitabine
label
Gemcitabine, docetaxel
type
EXPERIMENTAL

interventions

arm Group Labels
Gemcitabine, docetaxel
description
Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
name
docetaxel
other Names
Taxotere
type
DRUG
arm Group Labels
Gemcitabine, docetaxel
description
Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
name
Gemcitabine
other Names
Gemzar
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 36
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
measure
Response (Complete Response [CR] + Partial Response [PR])
time Frame
every 8 weeks for approximately 8 - 48 weeks

secondary Outcomes

description
Response duration in months
measure
Response Duration
time Frame
Every 8 weeks
description
Overall Survival using the Kaplan-Meier method
measure
Survival
time Frame
Every 8 weeks
description
Toxicity as the total number of participants with a given grade 3 and/or grade 4 adverse event
measure
Toxicity as Measured by Number and Grade of Adverse Events
time Frame
Every 2 weeks

Full study description

brief Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, 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: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with persistent, recurrent, or metastatic head and neck cancer.
detailed Description: OBJECTIVES: Primary * Determine the response rate in patients with previously treated persistent, recurrent, or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and docetaxel. Secondary * Determine the toxicity of this regimen in these patients. * Determine the duration of response and survival of patients treated with this regimen. OUTLINE: Patients receive gemcitabine IV over 30 minutes and docetaxel IV over 60 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 4 additional courses of therapy beyond documentation of CR. After completion of study treatment, patients are followed for survival. PROJECTED ACCRUAL: A total of 17-41 patients will be accrued within 42-49 months.

Source references