TriangleNCT00100789 · STUDY IN CONTEXT
S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. 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
Measured from time of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other normal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.
Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
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-malignant-head-and-neck-neoplasm
- nct id
- NCT00100789
- trial label
- S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- 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
- 4
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00100789
- outcome key
- om-0001
- source section id
- NCT00100789-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival
- endpoint definition
- Measured from time of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
- time origin
- 0 - 3 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible patients who started treatment were included in this measure.
- 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-malignant-head-and-neck-neoplasm
- nct id
- NCT00100789
- outcome key
- om-0000
- source section id
- NCT00100789-om-0000
- source outcome index
- 0
- endpoint
- Progression-free Survival
- endpoint definition
- Measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
- time origin
- 0 - 3 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible patients who started treatment were included in this measure.
- 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-malignant-head-and-neck-neoplasm
- nct id
- NCT00100789
- outcome key
- om-0002
- source section id
- NCT00100789-om-0002
- source outcome index
- 2
- endpoint
- Response
- endpoint definition
- Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other normal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.
- time origin
- 9 weeks - 3 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible patients with measurable disease who started treatment were included in response measures.
- 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-malignant-head-and-neck-neoplasm
- nct id
- NCT00100789
- outcome key
- om-0003
- source section id
- NCT00100789-om-0003
- source outcome index
- 3
- endpoint
- Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
- endpoint definition
- Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
- time origin
- Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
- 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-malignant-head-and-neck-neoplasm
- nct id
- NCT00100789
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Gemcitabine and Paclitaxel
- regimen
- Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
- analyzed count
- 63
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00100789-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00100789
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Gemcitabine and Paclitaxel
- regimen
- Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
- analyzed count
- 63
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00100789-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00100789
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Gemcitabine and Paclitaxel
- regimen
- Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Eligible patients who received any treatment were included in baseline measures.
- analyzed count
- 57
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00100789-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00100789
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Gemcitabine and Paclitaxel
- regimen
- Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
- analyzed count
- 63
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00100789-om-0003#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-head-and-neck-neoplasm
- nct id
- NCT00100789
- harm key
- EG000
- source section id
- NCT00100789-ae
- event group key
- EG000
- event group label
- Gemcitabine and Paclitaxel
- serious affected
- 0
- serious at risk
- 63
- other affected
- 54
- other at risk
- 63
- frequency threshold
- 5
- collection period
- Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
- event definition
- Source null
- 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