NCT00012363
S0101 Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus
PHASE2
COMPLETED
NCT00012363
INTERVENTIONAL
Gemcitabine Plus Irinotecan in Patients With Esophageal Cancer, Phase II
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.
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
Esophageal Cancer
Gastric Cancer
- TREATMENT
-
- Type: DRUG
- Name: gemcitabine hydrochloride
- Description: 1,000mg/m2, IV over 30 min, days 1 \& 8, q 21 days
- Arm Group Labels: Gemcitabine + Irinotecan
-
- Type: DRUG
- Name: irinotecan hydrochloride
- Description: 100 mg/m2, IV over 90 min, days 1 \& 8, q 21days
- Arm Group Labels: Gemcitabine + Irinotecan
- SWOG Cancer Research Network