Tarceva and Capecitabine for Pancreatic Cancer

Dana-Farber Cancer Institute

Status and phase

Completed

Phase 2

Conditions

Neoplasm Metastasis

Pancreatic Cancer

Treatments

Drug: OSI-774

Drug: Capecitabine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00125021

03-070

Details and patient eligibility

About

This phase II trial is designed to investigate the effectiveness of Tarceva (OSI-774) combined with capecitabine in treating patients with metastatic pancreatic cancer.

Full description

Patients will be treated once daily with Tarceva, twice daily with capecitabine for 14 consecutive days, followed by 7 days off of capecitabine (a cycle is 21 days). At week 1 of each cycle a physical exam and blood work will be performed. Reassessment of tumor size will be conducted at 6 weeks (2 cycles), 12 weeks (4 cycles) and then every 9 weeks thereafter. Patients will remain on treatment until one of the following occur: disease progression, illness that prevents further treatment or unacceptable adverse events.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Metastatic pancreatic carcinoma (excluding pancreatic endocrine tumors)
Only patients with measurable disease
ECOG performance status < or equal to 1
Life expectancy >12 weeks
Signed informed consent
Failed or intolerance to first-line therapy for metastatic disease with a gemcitabine-containing regimen. Patients may have received adjuvant therapy in addition to one prior regimen for metastatic disease.
>4 weeks must have elapsed from the completion of previous chemotherapy and patients must have recovered from any related toxicities
>4 weeks must have elapsed from the participation in any investigational drug study
Laboratory values:
- ANC > 1500/mm3;
- Hemoglobin > 9.0 gm/dl;
- Platelets > 100,000/mm3;
- SGOT <2.5 X upper limit of normal; or <5 X upper limit of normal if evidence of liver metastases; Alkaline phosphatase < 2.5 X upper limit of normal; or < 5 X upper limit of normal if evidence of liver metastases; Total bilirubin < 1.5 X upper limit of normal; Creatinine clearance > 50 cc/min (by Cockroft - Gault or as determined from a 24-hour urine collection).

Exclusion criteria

Prior therapy with capecitabine or epidermal growth factor receptor (EGFR) inhibitors
More than one prior chemotherapy treatment regimen for metastatic disease
Clinically apparent central nervous system (CNS) metastases or carcinomatous meningitis
Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication or heart attack within the last 12 months).
Major surgery within 4 weeks of the start of study treatment, without complete recovery.
Evidence of CNS metastases (unless CNS metastases have been stable for > 3 months) or history of uncontrolled seizures, central nervous system disorders
Uncontrolled serious medical or psychiatric illness
Women must not be pregnant or lactating
Concurrent radiation therapy
Other active malignancy
Inability to swallow tablets
Patients lacking physical integrity of the upper gastrointestinal tract or who have malabsorption syndrome
Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil