S0101 Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus

SWOG Cancer Research Network

Status and phase

Completed

Phase 2

Conditions

Gastric Cancer

Esophageal Cancer

Treatments

Drug: gemcitabine hydrochloride

Drug: irinotecan hydrochloride

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00012363

S0101 (Other Identifier)

CDR0000068515

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: