Status:
COMPLETED
Study of Gefitinib and Docetaxel as Salvage Therapy in Advanced Pancreatic Carcinoma
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
AstraZeneca
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Initial therapy for metastatic pancreatic carcinoma is inadequate, and there is no effective second line therapy. Docetaxel has known single agent activity in pancreatic carcinoma, resulting in a medi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00177242
Start Date
September 1 2004
End Date
December 1 2006
Last Update
January 18 2016
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232