Clinical trial · Interventional
S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer
A Phase II Study of Biweekly Gemcitabine and Paclitaxel (GEMTAX) Combination in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine together with paclitaxel may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel works in treating patients with persistent, recurrent, or metastatic head and neck cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine | Drug | Gemcitabine | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- gemcitabine paclitaxel combination
- interventionNames
- Drug: gemcitabine
- Drug: paclitaxel
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 0 - 3 years
- description
- 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.
Secondary outcomes (3)
- measure
- Progression-free Survival
- timeFrame
- 0 - 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN) * Recurrent, persistent, or newly diagnosed metastatic disease * Measurable or non-measurable disease * No active or prior CNS metastasis PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No serious organ dysfunction * No serious comorbid conditions that would preclude study treatment * No history of hypersensitivity reaction to products containing polysorbate 80 * No active infection requiring systemic antibiotic therapy * No symptomatic sensory neuropathy ≥ grade 2 * 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 * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent biologic or immunotherapy for SCCHN * No concurrent gene therapy for SCCHN Chemotherapy * No prior chemotherapy for recurrent or newly diagnosed metastatic disease * At least 6 months since prior induction or adjuvant chemotherapy * No more than 1 prior induction or adjuvant regimen * No prior gemcitabine or taxanes as part of induction, adjuvant, or neoadjuvant chemotherapy * No other concurrent chemotherapy for SCCHN Endocrine therapy * Not specified Radiotherapy * At least 28 days since prior radiotherapy and recovered * No concurrent radiotherapy for SCCHN Surgery * Not specified Other * No other concurrent therapy for SCCHN
References
Publications (0)
Data not yet available