Clinical trial · Interventional
Lapatinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
A Phase II Study Of GW572016 In Squamous Cell Carcinoma Of The Head And Neck (SCCHN)
NCT00098631CI-TRIAL-00013341completedPhase 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)
Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. This phase II trial is studying how well lapatinib works in treating patients with recurrent and/or metastatic head and neck cancer.
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Squamous Neck Cancer With Occult Primary | — | UNRESOLVED | — |
| Recurrent Metastatic Squamous Neck Cancer With Occult Primary | — | UNRESOLVED | — |
| Recurrent Squamous Cell Carcinoma of the Hypopharynx | Hypopharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Squamous Cell Carcinoma of the Larynx | Laryngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity | — | UNRESOLVED | — |
| Recurrent Squamous Cell Carcinoma of the Nasopharynx | — | UNRESOLVED | — |
| Recurrent Squamous Cell Carcinoma of the Oropharynx | Oropharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity | — | UNRESOLVED |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| lapatinib ditosylate | Drug | Lapatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (lapatinib ditosylate)
- description
- Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: lapatinib ditosylate
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Objective response rate by RECIST
- timeFrame
- Up to 6 years
- description
- The 95% confidence intervals should be provided.
- measure
- Progression-free survival (PFS)
- timeFrame
- From start of treatment to time of disease progression, assessed up to 6 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed squamous cell carcinoma of the head and neck * Recurrent and/or metastatic disease * Measurable disease * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * No more than 2 prior treatment regimens for recurrent or metastatic disease * Prior chemotherapy as part of initial curative intent therapy (e.g., neoadjuvant, adjuvant, or concurrent chemotherapy) is allowed and does not count as prior therapy for recurrent or metastatic disease * No known brain metastases * Performance status - ECOG 0-2 * Performance status - Karnofsky 60-100% * More than 3 months * Bilirubin normal * AST and ALT ≤ 2.5 times upper limit of normal * Creatinine normal * Creatinine clearance \> 60 mL/min * Cardiac ejection fraction normal by echocardiogram or MUGA * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Able to swallow and retain oral or feeding tube-administered medication * No malabsorption syndrome * No requirement for IV alimentation * No uncontrolled inflammatory gastrointestinal disease (e.g., Crohn's disease or ulcerative colitis) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of allergic reaction attributed to compounds of similar chemical or biologic composition to lapatinib * No other uncontrolled illness * No active or ongoing infection * No psychiatric illness or social situation that would preclude study compliance * Prior cetuximab allowed * See Disease Characteristics * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No prior cumulative anthracycline therapy ≥ 450 mg/m\^2 of doxorubicin or equivalent * More than 4 weeks since prior radiotherapy * No prior surgical procedure affecting absorption * Recovered from prior therapy * Other prior epidermal growth factor receptor inhibitors (e.g., gefitinib or erlotinib) allowed * Concurrent oral anticoagulants (e.g., warfarin) allowed provided there is increased vigilance in monitoring INR * No concurrent CYP3A4 inhibitors or inducers * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational agents * No other concurrent anticancer therapy
References
Publications (0)
Data not yet available
No reference posted for this study.