Study of Gefitinib and Docetaxel as Salvage Therapy in Advanced Pancreatic Carcinoma

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II, open-label trial of Gefitinib and docetaxel in patients having one prior regimen of chemotherapy for with metastatic pancreatic carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: AstraZeneca
• Treatments: Docetaxel; Gefitinib

Criteria

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the pancreas that is surgically inoperable

• Must have had one prior chemotherapeutic regimen for advanced disease (Prior radiation with a radiation sensitizer for locally advanced disease or adjuvant therapy is not considered a prior regimen for purpose of this study)

• Disease must be measurable by RECIST criteria; measurable disease will be defined as at least one lesion that can be accurately measured in at least one dimension measuring at least 2 cm conventional CT or MRI or 1 cm with spiral CT scans (Appendix A)

• Aged 18 years or older

• ECOG performance status of 0 - 2 (see Appendix B)

• Able to take oral medications without difficulty

• Adequate bone marrow function as evidenced by an ANC > 1500/mL and platelet count > 100, 000/mL

• Adequate renal function as evidenced by serum creatinine within institutional limits or creatinine clearance > 60 ml/minute if above upper institutional limits (ULN)

• Adequate hepatic function as evidenced by ALT, AST, and total bilirubin within ULN. If hepatic metastases are present, ALT and AST may be up to 5 x ULN.

• Provision of written informed consent

• Men and women of childbearing potential must be willing to practice acceptable methods of birth control to prevent pregnancy. This is a precautionary measure for use of Gefitinib and docetaxel.

Exclusion Criteria:

• Known severe hypersensitivity to Gefitinib or docetaxel or any of the excipients of these products (i.e. polysorbate 80)

• Previous treatment with Gefitinib or docetaxel.

• Other coexisting malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or squamous cell carcinoma of the skin or cervical cancer in situ.

• Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's Wort

• Treatment with a non-approved or investigational drug within 30 days before Day 1 of trial treatment.

• Treatment with radiation therapy or chemotherapy within 28 days before Day 1 of trial treatment

• Any unresolved chronic toxicity greater then CTC grade 2 from previous anticancer therapy (except alopecia)

• Incomplete healing from previous oncologic or other major surgery.

• Pregnancy or breast feeding (women of childbearing potential).

• Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).

• As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).

• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial.