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

NCT00177242 | Completed Phase 2 DMC

• 1 other identifier: 04-027
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

pancreas; pancreatic

Outcome Measures

Primary Outcomes (1)

• Ascertain the median survival of advanced pancreatic cancer patients treated with Gefitinib and docetaxel.

Secondary Outcomes (2)

• Determine the response rate, time to disease progression, survival rate at 6- month intervals after treatment start, and safety profile of Gefitinib and docetaxel as treatment for advanced pancreatic cancer

• Determine the time course of serial CA19-9 measurements during treatment.

Interventions

Gefitinib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• AstraZeneca: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (1)

• Ramanathan RK, Abbruzzese J, Dragovich T, Kirkpatrick L, Guillen JM, Baker AF, Pestano LA, Green S, Von Hoff DD. A randomized phase II study of PX-12, an inhibitor of thioredoxin in patients with advanced cancer of the pancreas following progression after a gemcitabine-containing combination. Cancer Chemother Pharmacol. 2011 Mar;67(3):503-9. doi: 10.1007/s00280-010-1343-8. Epub 2010 May 12.

  PMID: 20461382 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Gefitinib

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kenneth Foon, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2004
• Study Completion: December 1, 2006
• Last Updated: January 18, 2016

Record last verified: 2016-01

Locations

US (1)