Docetaxel in Combination With Iressa in Previously Treated Patients With Pancreatic Cancer
This study has been completed.
Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00137761
First received: August 26, 2005
Last updated: October 30, 2009
Last verified: October 2009
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Purpose
The purpose of this study is to find out what activity the combination of docetaxel and Iressa have against metastatic pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Pancreatic Carcinoma |
Drug: ZD 1839 Drug: Docetaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Docetaxel in Combination With ZD 1839 (IRESSA) in Previously Treated Patients With Metastatic Pancreatic Cancer |
Resource links provided by NLM:
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- To determine the response rate of Iressa and docetaxel in patients with advanced pancreatic cancer following failure of gemcitabine-based therapy [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine the safety, radiologic response rate, progression-free survival and overall survival of patients treated with Iressa and docetaxel [ Time Frame: TBD ] [ Designated as safety issue: Yes ]
| Enrollment: | 32 |
| Study Start Date: | October 2004 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: ZD 1839
Taken orally once daily
Other Name: Iressa
Drug: Docetaxel
Given intravenously once weekly for 2 out of 3 weeks
Iressa will be taken orally once daily without interruption. Docetaxel will be administered intravenously once weekly for two out of every three weeks. Patients will also receive dexamethasone the night prior, morning of, and the evening after docetaxel treatment to help prevent an allergic reaction.
Every week that chemotherapy is given, blood tests and vital signs will be taken.
After the first 6 weeks of therapy a CT scan (or other radiological procedure) will be done to assess the progress of the disease. If the cancer is responding to the treatment and no unacceptable side effects have occured, treatment with Iressa and docetaxel will continue.
CT scans (or other radiological procedure) will be performed at week 12 and every 9 weeks thereafter to monitor the progress of the disease.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Metastatic pancreatic carcinoma (excluding pancreatic endocrine tumors); histologic confirmation of either the primary or metastatic site.
- ECOG performance status of < 1
- > 4 weeks since completion of previous chemotherapy
- > 4 weeks since participation in any investigational drug study
- Peripheral neuropathy of grade < 1
- Patients must have failed a gemcitabine-containing regimen administered in the metastatic, adjuvant, or locally advanced setting.
- Absolute neutrophil count (ANC) > 1,500/mm3
- Hemoglobin > 9.0gm/dl
- Platelets > 100,000/mm3
- Total bilirubin < 2.0mg/dl
- AST and alkaline phosphatase < 5 x upper limit of normal (ULN)
- Albumin > 2.5gm/dl
- CA 19-9 > 1.5 x ULN
Exclusion Criteria:
- Prior therapy with taxane or with epidermal growth factor receptor (EGFR) inhibitors
- More than one prior chemotherapy treatment
- Clinically significant cardiac disease
- Major surgery within 4 weeks of the start of study treatment
- Evidence of central nervous system (CNS) metastases or carcinomatous meningitis or history of uncontrolled seizures, central nervous system disorders.
- Uncontrolled serious medical or psychiatric illness
- Pregnant or breast-feeding women
- Other active malignancy
- Inability to swallow tablets or evidence of a gastrointestinal malabsorption syndrome
- Known severe hypersensitivity to Iressa
- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St. John's wort.
- History of severe hypersensitivity reaction to drugs formulated with polysorbate 80
- Any evidence of clinically active interstitial lung disease
- Ascites requiring paracentesis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137761
Locations
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Investigators
| Principal Investigator: | Matthew Kulke, MD | Dana-Farber Cancer Institute |
More Information
No publications provided
| Responsible Party: | Matthew Kulke, MD, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00137761 History of Changes |
| Other Study ID Numbers: | 04-173 |
| Study First Received: | August 26, 2005 |
| Last Updated: | October 30, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dana-Farber Cancer Institute:
|
Pancreatic Carcinoma Iressa Docetaxel |
Additional relevant MeSH terms:
|
Carcinoma Pancreatic Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases |
Endocrine System Diseases Docetaxel Gefitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013