TriangleNCT00588770 · STUDY IN CONTEXT
Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
These were blood and tissue samples collections and have no data to report.
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).
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer-recurrent-79ac7906
- nct id
- NCT00588770
- trial label
- Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 5
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer-recurrent-79ac7906
- nct id
- NCT00588770
- outcome key
- om-0003
- source section id
- NCT00588770-om-0003
- source outcome index
- 3
- endpoint
- To Collect Blood Samples Before and After Therapy for Future Correlative Studies
- endpoint definition
- These were blood and tissue samples collections and have no data to report.
- time origin
- Before and after therapy
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer-recurrent-79ac7906
- nct id
- NCT00588770
- outcome key
- om-0004
- source section id
- NCT00588770-om-0004
- source outcome index
- 4
- endpoint
- To Collect Tumor Tissue Samples Available at Baseline From Prior Diagnostic Procedures for Future Correlative Studies
- endpoint definition
- These were blood and tissue samples collections and have no data to report.
- time origin
- Baseline
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer-recurrent-79ac7906
- nct id
- NCT00588770
- outcome key
- om-0000
- source section id
- NCT00588770-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival (OS)
- endpoint definition
- 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.
- time origin
- assessed every 3 months within 2 years from study entry, then every 6 months up to 5 years from study entry
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized patients
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer-recurrent-79ac7906
- nct id
- NCT00588770
- outcome key
- om-0001
- source section id
- NCT00588770-om-0001
- source outcome index
- 1
- endpoint
- Progression-free Survival (PFS)
- endpoint definition
- 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.
- time origin
- on both arms, assessed every 2 cycles during chemotherapy treatment, then assessed every 9 weeks until progression up to 5 years from study entry; patients on arm B were assessed every 2 cycles for additional 12 weeks before changing to every 9 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized patients
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer-recurrent-79ac7906
- nct id
- NCT00588770
- outcome key
- om-0002
- source section id
- NCT00588770-om-0002
- source outcome index
- 2
- endpoint
- Overall Response Rate
- endpoint definition
- 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).
- time origin
- on both arms, assessed every 2 cycles during chemotherapy treatment, then assessed every 9 weeks until progression up to 5 years from study entry; patients on arm B were assessed every 2 cycles for additional 12 weeks before changing to every 9 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized patients
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer-recurrent-79ac7906
- nct id
- NCT00588770
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Chemotherapy Arm (Arm A)
- regimen
- 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.
- analyzed count
- 200
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00588770-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer-recurrent-79ac7906
- nct id
- NCT00588770
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Chemotherapy+Bevacizumab (Arm B)
- regimen
- 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.
- analyzed count
- 203
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00588770-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer-recurrent-79ac7906
- nct id
- NCT00588770
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Chemotherapy Arm (Arm A)
- regimen
- 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.
- analyzed count
- 200
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00588770-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer-recurrent-79ac7906
- nct id
- NCT00588770
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Chemotherapy+Bevacizumab (Arm B)
- regimen
- 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.
- analyzed count
- 203
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00588770-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer-recurrent-79ac7906
- nct id
- NCT00588770
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Chemotherapy Arm (Arm A)
- regimen
- 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.
- analyzed count
- 200
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00588770-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer-recurrent-79ac7906
- nct id
- NCT00588770
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Chemotherapy+Bevacizumab (Arm B)
- regimen
- 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.
- analyzed count
- 203
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00588770-om-0002#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer-recurrent-79ac7906
- nct id
- NCT00588770
- harm key
- EG000
- source section id
- NCT00588770-ae
- event group key
- EG000
- event group label
- Chemotherapy (Arm A)
- serious affected
- 135
- serious at risk
- 199
- other affected
- 50
- other at risk
- 199
- frequency threshold
- 5
- collection period
- Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events)
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer-recurrent-79ac7906
- nct id
- NCT00588770
- harm key
- EG001
- source section id
- NCT00588770-ae
- event group key
- EG001
- event group label
- Chemotherapy + Bevacizumab (Arm B)
- serious affected
- 162
- serious at risk
- 193
- other affected
- 50
- other at risk
- 193
- frequency threshold
- 5
- collection period
- Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events)
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice