Clinical trial · Interventional
PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus
A Phase II Multicenter Study of the Efficacy and Safety Study of PNU-93914 (Liposome Encapsulated Paclitaxel) in Patients With Advanced Esophageal Cancer Previously Exposed to Chemotherapy
NCT00016900CI-TRIAL-00010754completedPhase 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. PURPOSE: Phase II trial to study the effectiveness of PNU-93914 in treating patients who have locally advanced or metastatic cancer of the esophagus.
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 |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| liposomal paclitaxel | Drug | Paclitaxel Liposome | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus Tumors of the gastroesophageal junction allowed if at least 50% of the tumor involved the esophagus at time of initial diagnosis Locally advanced or metastatic disease that is not amenable to surgery or radiotherapy with curative intent Progressive disease after 1 chemotherapy regimen for locally advanced or metastatic disease Relapse within 6 months of completing prior neoadjuvant chemotherapy allowed Chemotherapy administered solely as a radiosensitizer not considered a prior chemotherapy regimen At least 1 non-irradiated measurable target lesion At least 20 mm in at least 1 dimension by conventional techniques OR At least 10 mm in at least 1 dimension by spiral CT scan No known brain metastases, spinal cord compression, or carcinomatous meningitis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN (5 times ULN if hepatic metastases present) Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min Cardiovascular: No myocardial infarction within the past 6 months No unstable angina No New York Heart Association class III or IV heart disease No severe uncontrolled cardiac arrhythmia Other: HIV negative No active infection No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, basal cell skin cancer, or squamous cell carcinoma of the head and neck within the past 3 years No concurrent malignancies at other sites No psychiatric or other disorder that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent anticancer biologic response modifiers or immunotherapy No concurrent sargramostim (GM-CSF) No concurrent prophylactic filgrastim (G-CSF) during first course of study Chemotherapy: See Disease Characteristics Recovered from prior chemotherapy No prior taxane therapy No other concurrent anticancer chemotherapy Endocrine therapy: No concurrent anticancer hormonal therapy Radiotherapy: See Disease Characteristics Recovered from prior radiotherapy Surgery: See Disease Characteristics Recovered from prior surgery Other: At least 4 weeks since prior investigational agent No other concurrent investigational therapy No concurrent participation in other clinical study No other concurrent antitumor therapy
References
Publications (0)
Data not yet available
No reference posted for this study.