Clinical trial · Interventional
Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Phase II Trial of Irinotecan Plus Cisplatin in Patients With Recurrent or Metastatic Squamous Carcinoma of the Head and Neck
NCT00639769CI-TRIAL-00008025completedPhase 2Results postedClinicalTrials.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, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: To determine if CPT-11 given together with cisplatin is effective in treating 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 |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Therapeutic Intervention
- interventionNames
- Drug: cisplatin
- Drug: irinotecan hydrochloride
Primary outcomes (1)
- measure
- Patient Response
- timeFrame
- 6 weeks after last chemotherapy treatment
- description
- Number of patients in each response category according to RECIST criteria: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
Secondary outcomes (1)
- measure
- Number of Patients With Each Worst-grade Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed squamous cell carcinoma of the head and neck that is considered incurable with surgery or radiotherapy
* Meets one of the following criteria:
* Previously untreated disease
* Newly diagnosed disease with distant metastases
* Recurrent or persistent disease
* Local-regional recurrence/persistence or distant metastases after initial treatment with surgery or radiotherapy
* No locally advanced unresectable disease that was not previously treated with radiotherapy
* Bidimensionally measurable disease
* If the only measurable disease is within the radiotherapy port, there must be biopsy-proven recurrence ≥ 8 weeks after the completion of radiotherapy
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 12 weeks
* Creatinine clearance ≥ 50 mL/min
* SGOT ≤ 3 times upper limit of normal
* Serum bilirubin \< 1.5 mg/dL
* Granulocytes ≥ 1,500/mm \^3
* Platelet count \> 100,000/mm\^3
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No significant detectable infection
* No co-morbid disease unless under adequate control
* No other cancer within the past 3 years except basal cell or squamous cell skin cancer or early-stage prostate cancer
Exclusion Criteria:
-Pregnant or lactating women
Not specified
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from any prior major surgery
* No prior chemotherapy for recurrent or metastatic disease
* Patients who completed neoadjuvant, concurrent, or adjuvant chemotherapy ≥ 3 months prior to recurrence will be considered chemotherapy-naive
* Patients who completed neoadjuvant, concurrent, or adjuvant chemotherapy \< 3 months prior to recurrence will be considered chemotherapy failures
* No prior therapy with topotecan or irinotecan hydrochloride
* At least 4 weeks since prior biologic therapy (e.g., interleukin-2, interferon, megestrol acetate)References
Publications (1)
- RESULTGilbert J, Cmelak A, Shyr Y, Netterville J, Burkey BB, Sinard RJ, Yarbrough WG, Chung CH, Aulino JM, Murphy BA. Phase II trial of irinotecan plus cisplatin in patients with recurrent or metastatic squamous carcinoma of the head and neck. Cancer. 2008 Jul 1;113(1):186-92. doi: 10.1002/cncr.23545. PMID 18484593