Clinical trial · Interventional
S0007 - Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
Evaluation of Three Hour Infusion of Paclitaxel Plus Cisplatin and 5-Fluorouracil in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
NCT00006248CI-TRIAL-00009973completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic or recurrent 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Every 3 weeks while on protocol treatment, then every 3 months for the first year, and then every 6 years thereafter for up to 3 years.
- description
- Overall survival was defined as the duration from the date of registration until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the head and neck * Metastatic at diagnosis or persistent, metastatic, or recurrent after surgery and/or radiotherapy * Relapse after prior induction or adjuvant therapy allowed * No newly diagnosed nonmetastatic disease * Measurable or nonmeasurable disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 50 mL/min Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No grade 2 or greater sensory neuropathy * No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent biologic therapy Chemotherapy: * See Disease Characteristics * At least 6 months since prior carboplatin or cisplatin induction or adjuvant chemotherapy * No more than 1 prior induction or adjuvant chemotherapy regimen * No prior chemotherapy for recurrent or newly diagnosed metastatic disease * No other concurrent chemotherapy Endocrine therapy: * No concurrent anticancer hormonal therapy Radiotherapy: * See Disease Characteristics * At least 28 days since prior radiotherapy and recovered * No concurrent radiotherapy Surgery: * See Disease Characteristics * At least 28 days since prior surgery and recovered
References
Publications (1)
- RESULTWorden FP, Moon J, Samlowski W, Clark JI, Dakhil SR, Williamson S, Urba SG, Ensley J, Hussain MH; Southwest Oncology Group, Head and Neck Working Group. A phase II evaluation of a 3-hour infusion of paclitaxel, cisplatin, and 5-fluorouracil in patients with advanced or recurrent squamous cell carcinoma of the head and neck: Southwest Oncology Group study 0007. Cancer. 2006 Jul 15;107(2):319-27. doi: 10.1002/cncr.21994. PMID 16779801