Nab-paclitaxel (Abraxane), Gemcitabine, and Capecitabine (Xeloda) for Pancreatic Adenocarcinoma

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate optimal dose and safety of the combination of Abraxane, gemcitabine, and Xeloda (capecitabine) (AGX) as first-line therapy in patients with metastatic pancreatic cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Celgene Corporation
• Treatments: Albumin-Bound Paclitaxel; Capecitabine; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

1. Histologically-confirmed pancreatic adenocarcinoma

2. Stage IV disease (metastatic only)

3. No prior systemic therapy for their diagnosis (except in adjuvant setting > six months previously)

4. ECOG performance score of 0-1

5. At least 18 years of age

6. Evidence of either or both of the following:

• RECIST-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20mm using conventional techniques or ≥10 mm with spiral CT scan)

• An elevated serum CA19-9 at baseline ( ≥ 2X ULN)

7. Female patients must be either surgically sterile or postmenopausal, or if of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment and agree to use effective barrier contraception during the period of therapy. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the investigator.

8. Adequate bone marrow function:

• ANC ≥ 1500/uL

• platelet count ≥ 100,000/uL

• hemoglobin ≥ 9.0 g/dL

• Total bilirubin ≤ 1.5 X ULN

• AST (SGOT) ≤ 2.5 X ULN

• ALT (SGPT) ≤ 2.5 X ULN

10. Adequate renal function as determined by either:

• Calculated or measured creatinine clearance ≥ 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used). The Modified Cockcroft-Gault formula is as follows:

((140 - age(yrs)) x (actual weight(kg))) / (72 x serum creatinine(mg/dl))

• Multiply by another factor of 0.85 if female

• Serum creatinine ≤ 1.5 X ULN 11. Ability to swallow oral medications 12. Ability to understand the nature of this study protocol and give written informed consent 13. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

1. Any prior systemic or investigational therapy for metastatic pancreatic cancer. Systemic therapy administered alone or in combination with radiation in the adjuvant setting is permissible as long as it was completed > 6 months prior to the time of study enrollment.

2. Inability to comply with study and/or follow-up procedures.

3. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.

4. Presence of central nervous system or brain metastases.

5. Life expectancy < 12 weeks

6. Pregnancy (positive pregnancy test) or lactation.

7. Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other form of cancer from which the patient has been disease-free for 5 years.

8. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.

9. Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.

10. Known, existing uncontrolled coagulopathy.

11. Pre-existing sensory neuropathy > grade 1.

12. Major surgery within 4 weeks of the start of study treatment, without complete recovery.

13. Concurrent/pre-existing use of coumadin.