Tarceva and Capecitabine for Pancreatic Cancer

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00125021

Collaborator

Genentech, Inc. (Industry), Roche Global Development (Other), Brigham and Women's Hospital (Other), Massachusetts General Hospital (Other), Beth Israel Deaconess Medical Center (Other)

Enrollment

Locations

Duration (Months)

10.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Neoplasm Metastasis	Drug: Capecitabine Drug: OSI-774	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of OSI-774 (Tarceva) in Combination With Capecitabine in Previously Treated Patients With Metastatic Pancreatic Cancer

Study Start Date :

Oct 1, 2003

Actual Primary Completion Date :

Jun 1, 2004

Actual Study Completion Date :

Sep 1, 2008

Outcome Measures

Primary Outcome Measures

To assess the response rate associated with capecitabine and OSI-774 in patients with advanced pancreatic cancer []

Secondary Outcome Measures

To assess the side effects of capecitabine and OSI-774 in patients with advanced pancreatic cancer [2 years]
to estimate the time to progression and overall survival of patients with advanced pancreatic cancer treated with capecitabine and OSI-774 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02115
3	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115