Neoplasms

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Mouth and Tooth Diseases

Rare Diseases

Carcinoma

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Head and Neck Neoplasms

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Carcinoma, Verrucous

Salivary Gland Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Unknown Primary

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Squamous Cell

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Neoplasm Metastasis

Neoplastic Processes

Oral Squamous Cell Carcinoma

Oral Cancer

Tongue Cancer

All Drugs and Chemicals

Antineoplastic Agents

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Antibodies, Monoclonal

Carboplatin

Bevacizumab

Docetaxel

Fluorouracil

Cisplatin

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Immunoglobulin G

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Immunoglobulins, Intravenous

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immunologic Factors

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Patients receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA.

Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients receive bevacizumab as in Arm IB and docetaxel and carboplatin as in Arm IIA.

Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA.

Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.

Laboratory Biomarker Analysis

Athanassios (Ethan) Argiris

This randomized phase III trial studies chemotherapy to see how well it works with or without bevacizumab in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or that has spread to other parts of the body (metastatic). Drugs used in chemotherapy, such as docetaxel, cisplatin, carboplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also make tumor cells more sensitive to chemotherapy and stop the growth of head and neck cancer by blocking blood flow to the tumor. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab in treating patients with head and neck squamous cell carcinoma.

PRIMARY OBJECTIVES:

I. To compare the overall survival of patients with recurrent or metastatic head and neck cancer treated with standard platinum-based chemotherapy with or without bevacizumab.

SECONDARY OBJECTIVES:

I. To assess toxicities with the addition of bevacizumab to each platinum-doublet (cisplatin/docetaxel, carboplatin/docetaxel, cisplatin/fluorouracil \[5-FU\], carboplatin/5-FU).

II. To compare the objective response rates and the progression-free survival achieved with the above therapies.

III. To collect blood samples before and after therapy for future correlative studies.

IV. To collect tumor tissue samples available at baseline from prior diagnostic procedures for future correlative studies.

OUTLINE: After the physician decides which chemotherapy doublet to use, patients are randomized to 1 of 2 treatment arms for that chemotherapy combination.

ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA.

ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA.

ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA.

ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer

These were blood and tissue samples collections and have no data to report.

Overall survival (OS) was defined as time from randomization to death from any course. Patients who were alive were censored at the last contact date. Median OS was estimated using the Kaplan-Meier method.

Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression-free survival (PFS) was defined as the time from randomization to date of disease progression or death from any cause, whichever occurred first. Patients who were still alive and progression free were censored at last disease assessment date. Median PFS was estimated using Kaplan-Meier method.

Overall response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all patients. Responses are evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as disappearance of target lesions or at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s).

National Cancer Institute (NCI)

At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population.

A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.

ARM A: Patients receive one of the four chemotherapy regimens

ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Chemotherapy (Arm A)

ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A

ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA.

ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA.

ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA.

ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.

Chemotherapy + Bevacizumab (Arm B)

Chemotherapy Arm (Arm A)

Chemotherapy+Bevacizumab (Arm B)

Total

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

Study statistician

The study hypothesis is that the addition of bevacizumab will improve the median survival by 35% from 8.5 months (based on E1395 and E5397) to 11.5 months.

ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A

ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA.

ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA.

Regimen 2:

ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA.

Regimen 2 carbo:

ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma	NCT00588770	Neck Squamous C... Recurrent Hypop... Recurrent Laryn... Recurrent Laryn... Recurrent Lip a... Recurrent Neck ... Recurrent Oral ... Recurrent Oroph... Recurrent Saliv... Recurrent Sinon... Salivary Gland ... Stage IV Hypoph... Stage IV Major ... Stage IVA Laryn... Stage IVA Laryn... Stage IVA Lip a... Stage IVA Major... Stage IVA Oral ... Stage IVA Oroph... Stage IVA Sinon... Stage IVB Laryn... Stage IVB Laryn... Stage IVB Lip a... Stage IVB Major... Stage IVB Oral ... Stage IVB Oroph... Stage IVB Sinon... Stage IVC Laryn... Stage IVC Laryn... Stage IVC Lip a... Stage IVC Major... Stage IVC Oral ... Stage IVC Oroph... Stage IVC Sinon... Tongue Carcinom...	Bevacizumab Carboplatin Cisplatin Docetaxel Fluorouracil Laboratory Biom...	18 Years -	National Cancer Institute (NCI)
Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma	NCT00588770	Neck Squamous C... Recurrent Hypop... Recurrent Laryn... Recurrent Laryn... Recurrent Lip a... Recurrent Neck ... Recurrent Oral ... Recurrent Oroph... Recurrent Saliv... Recurrent Sinon... Salivary Gland ... Stage IV Hypoph... Stage IV Major ... Stage IVA Laryn... Stage IVA Laryn... Stage IVA Lip a... Stage IVA Major... Stage IVA Oral ... Stage IVA Oroph... Stage IVA Sinon... Stage IVB Laryn... Stage IVB Laryn... Stage IVB Lip a... Stage IVB Major... Stage IVB Oral ... Stage IVB Oroph... Stage IVB Sinon... Stage IVC Laryn... Stage IVC Laryn... Stage IVC Lip a... Stage IVC Major... Stage IVC Oral ... Stage IVC Oroph... Stage IVC Sinon... Tongue Carcinom...	Bevacizumab Carboplatin Cisplatin Docetaxel Fluorouracil Laboratory Biom...	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for neck squamous cell carcinoma of unknown primary