Phase 2
N=50
A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers
Cholangiocarcinoma Cancer · Gallbladder Cancer · Pancreatic Cancer · Ampullary Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00660699 ↗Enrolled (actual)
50
Serious AEs
33.3%
Results posted
May 2015
Primary outcome: Primary: Incidence of Severe Toxicities — 20 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gemcitabine (Drug); Docetaxel (Drug); Radiation (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Severe Toxicities |
20 | — |
| SECONDARY Toxicities Associated With Treatment (Grade 1-2) |
31; 48; 23; 31; 17; 27 | — |
| SECONDARY Toxicities Associated With Treatment (Grade 3-4) |
2; 4; 4; 15; 4; 0 | — |
| SECONDARY Disease Free Survival (DFS) - Median |
12.8; 15.0 | — |
| SECONDARY Overall Survival (OS) - Median |
24.5; 23.8 | — |
| SECONDARY Overall Survival (OS) |
78.6; 81.2 | — |
| SECONDARY Overall Survival (OS) |
78.6; 81.2 | — |
Summary
To assess the feasibility of administering induction chemotherapy with gemcitabine and docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation gemcitabine/docetaxel chemotherapy.
Eligibility Criteria
Inclusion Criteria
- Patients must have biopsy-proven, resected with curative intent cholangiocarcinoma, gallbladder, pancreatic or ampullary adenocarcinoma.
- Patients must be 18 years or older.
- Patients must have a NCI CTC Performance Status of 0-2.
- Patients must not have any prior chemotherapy or radiation therapy for this current malignancy.
- At least 3 weeks should have elapsed since any surgery requiring general anesthesia.
- Patients must have no prior malignancies except for basal or squamous skin cancers, cervical carcinoma-in-situ, unless in remission for >5years
- Pregnant patients are not eligible. Non-pregnant status will be determined in all women of childbearing potential. All patients will be required to use an effective means of contraception if sexually active during therapy.
- Initial Required Laboratory Values:
- Absolute neutrophil count ≥ 1, 500/mm3, platelet count ≥ 150, 000/mm3, and hemoglobin ≥ 9 g/dL.
- Serum creatinine should be ≤ 2 mg/dL.
- Serum bilirubin should be ≤ 3.0 mg/dL (biliary stents allowed).
- Serum transaminases should be ≤ 5-fold the institutional upper limits.
- Patients must not have any co-existing severe medical illnesses, such as unstable angina, uncontrolled diabetes mellitus, uncontrolled arrhythmia or uncontrolled infection.
- Patients must be able to sign an informed consent.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT00660699). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.