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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00012363
Enrollment
61
Registered
2003-01-27
Start date
2001-04-30
Completion date
2006-04-30
Last updated
2012-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer, Gastric Cancer

Keywords

stage IV gastric cancer, recurrent gastric cancer, stage IV esophageal cancer, recurrent esophageal cancer, adenocarcinoma of the stomach, squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagus

Brief summary

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.

Detailed description

OBJECTIVES: * Determine the 6-month survival rate of patients with metastatic or recurrent carcinoma of the esophagus or gastroesophageal junction treated with gemcitabine and irinotecan. * Determine the qualitative and quantitative toxic effects of this regimen in these patients. OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study.

Interventions

DRUGgemcitabine hydrochloride

1,000mg/m2, IV over 30 min, days 1 & 8, q 21 days

DRUGirinotecan hydrochloride

100 mg/m2, IV over 90 min, days 1 & 8, q 21days

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
SWOG Cancer Research Network
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
6-month survival rate6 months after registrationTo assess the six-month survival rate in patients with esophageal cancer treated with a gemcitabine-irinotecan combination chemotherapy regimen.

Secondary

MeasureTime frameDescription
ToxicitiesWeek 1 and Week 2 of each cycleTo assess the qualitative and quantitative toxicities associated with this regimen in a Phase II study.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026