Phase 2
N=38
Low Dose Upper Abdominal Radiation Therapy (LD-UART) + Gemcitabine in Patients With Advanced, Unresectable Pancreatic Cancer (PC)
Gastrointestinal Neoplasms · Ovarian Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00390182 ↗Enrolled (actual)
38
Serious AEs
44.7%
Results posted
Apr 2014
Primary outcome: Primary: Overall Response — 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gemcitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response |
3 | — |
Summary
The purposes of this study are:
1. To assess the maximum tolerated dose of low-dose UART(Upper Abdominal Radiation Therapy ) or WART(Whole Abdominal Radiation Therapy) given in combination with standard fixed dose-rate Gemcitabine in patients with advanced gastrointestinal (GI) or ovarian tumors (Phase I).
2. To assess response rate and survival in advanced upper GI tumors following completion of therapy (Phase II).
Eligibility Criteria
Inclusion Criteria
- Patients are eligible if they have newly diagnosed histologically confirmed locally advanced or metastatic tumors of the pancreas. Patients must be felt to be unresectable by surgical criteria or felt to be medically inoperable. Patients may also be Stage IV with metastatic disease to the liver. Patients with bone and/or lung metastasis may be included at the investigators discretion.
- Patients must have measurable disease by CT scan.
- Patients must be able to give informed consent. Patients must be older than 18 years of age.
- Patients should have adequate bone marrow, renal, and hepatic function including: Bilirubin less than 1.25 x institutional normal LDH SGPT, SGOT, and alkaline phosphatase less than3 x institutional normal Serum creatinine less than or equal to 3 mg/dl. Absolute neutrophil count of greater than 1500 Hemoglobin greater than 9 gm per dl Platelet count greater than 100,000 WBC greater than 3000 cells per mcl
- Women of child-bearing potential must be agreeable to adequate contraception.(hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.)
- Patients must have a Karnofsky performance status of greater than or equal 60 or Zubrod of less or equal to 2.
- Life expectancy of at least 3 months.
- May have had a second malignancy or multiple malignancies if adequately controlled by clinical means. patients with more than one type of cancer must be cleared by the principal investigator.
- Patients must be at least 1 week from any major operative procedure.
10 .Patients may have brain metastasis if these brain metastasis are well controlled by usual clinical criteria and if the life expectancy is at least 3 months. Any patient with brain metastasis must be cleared by the principal investigator.
Exclusion Criteria
- Active infection requiring intravenous (IV) antibiotics at the time of entry.
- Cerebral metastasis which has not been adequately controlled.
- Significant malnutrition, cachexia, inundation or inability to give informed consent by clinical assessment.
- Concurrent chemotherapy not prescribed in this protocol.
- Any significant medical problems such as diabetes, cardiomyopathy or hypertension which is not reasonably controlled
- Prior radiation or chemotherapy
Data sourced from ClinicalTrials.gov (NCT00390182). 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.