Clinical trial · Interventional
S0101 Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus
Gemcitabine Plus Irinotecan in Patients With Esophageal Cancer, Phase II
NCT00012363CI-TRIAL-00007188completedPhase 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 cancer of the esophagus.
Conditions
Conditions (2)
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 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine + Irinotecan
- description
- Gemcitabine 1000mg/m2 IV over 30 min on Days 1,8 q21days; Irinotecan 100mg/m2 IV over 90 min on Days 1,8 q21days
- interventionNames
- Drug: gemcitabine hydrochloride
- Drug: irinotecan hydrochloride
Primary outcomes (1)
- measure
- 6-month survival rate
- timeFrame
- 6 months after registration
- description
- To assess the six-month survival rate in patients with esophageal cancer treated with a gemcitabine-irinotecan combination chemotherapy regimen.
Secondary outcomes (1)
- measure
- Toxicities
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic or recurrent carcinoma of the esophagus or gastroesophageal junction * Squamous cell carcinoma OR * Adenocarcinoma * No known brain metastases PATIENT CHARACTERISTICS: Age: * 18 to 100 Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Not specified Renal: * Creatinine no greater than 1.5 times upper limit of normal Cardiovascular: * No uncontrolled hypertension * No unstable angina * No symptomatic congestive heart failure * No myocardial infarction within the past 6 months * No serious uncontrolled cardiac arrhythmia Gastrointestinal: * No active inflammatory bowel disease * No significant bowel obstruction * No chronic diarrhea Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No active infection requiring systemic therapy * 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 adequately treated stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 28 days since prior biologic therapy * No prior biologic therapy for metastatic or recurrent disease * No concurrent sargramostim (GM-CSF) * No concurrent immunotherapy for tumor Chemotherapy: * At least 28 days since prior chemotherapy * No prior chemotherapy for metastatic or recurrent disease * No prior gemcitabine or irinotecan * Prior adjuvant or neoadjuvant chemotherapy at time of initial diagnosis of localized disease allowed * No other concurrent chemotherapy for tumor Endocrine therapy: * See Disease Characteristics * At least 28 days since prior endocrine therapy * No prior endocrine therapy for metastatic or recurrent disease * No concurrent hormonal therapy for tumor Radiotherapy: * At least 28 days since prior radiotherapy * No prior radiotherapy for metastatic or recurrent disease * Prior adjuvant or neoadjuvant radiotherapy at time of initial diagnosis of localized disease allowed * No concurrent radiotherapy for tumor Surgery: * Prior thoraco-abdominal surgery allowed * At least 3 weeks since prior surgery and recovered Other: * No other concurrent anti-cancer therapy for tumor
References
Publications (1)
- RESULTWilliamson SK, McCoy SA, Gandara DR, Dakhil SR, Yost KJ, Paradelo JC, Atkins JN, Blanke CD, Abbruzzese JL; Southwest Oncology Group (SWOG). Phase II trial of gemcitabine plus irinotecan in patients with esophageal cancer: a Southwest Oncology Group (SWOG) trial. Am J Clin Oncol. 2006 Apr;29(2):116-22. doi: 10.1097/01.coc.0000199883.10685.2b. PMID 16601427