Clinical trial · Interventional
A Study of Gemzar, Taxotere, and Xeloda for Adjuvant Pancreatic Cancer
A Phase II Study of Gemzar, Taxotere, and Xeloda (GTX) for Adjuvant Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this study will be to evaluate the toxicities as well as the efficacy of a chemotherapy regimen involving the combination of Gemzar, Taxotere, and Xeloda (GTX) in patients with pancreatic cancer, who have undergone complete surgical resection of their tumor. During the screening evaluation, subjects will have a physical exam and medical history taken by either the PI or a Co investigator. In addition, routine blood tests and radiological exams will be performed, to determine eligibility. Following enrollment, patients will receive 8 cycles (1 cycle = 21 days) of GTX treatment over 6 months. During each cycle patients will receive Gemzar and Taxotere on days 4 and 11, through an IV, over the course of approximately 2 hours, and Xeloda will be taken orally for the first 14 days of every cycle. Patients will receive no treatment on days 15 thru 21 of each cycle. During each cycle of treatment patients will have a physical examination, as well as routine blood work. The first scan will be done prior to initiation of treatment, and the next will be done at completion of chemotherapy. A short quality of life questionnaire will also be administered prior to cycle 1 treatment, at the 3-month point, and at the completion of chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine, Docetaxel, Capecitabine GTX
- description
- GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
- interventionNames
- Drug: Gemcitabine
- Drug: Docetaxel
- Drug: Capecitabine
Primary outcomes (1)
- measure
- Number of Subjects Who Experience Dose Limiting Toxicities (DLTs)
- timeFrame
- At days 4, 11, and follow-up.
- description
- Safety of the GTX regimen in patients with resected pancreatic cancer, using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Data was not analyzed because original PI left institution before data analysis was completed.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of pancreas that has been completely resected. Patients may be node negative or node-positive, but must have clean margins of resection. * Ineligible for other high priority national or institutional studies. * Time from surgical recovery greater than three weeks, but less than six weeks. * All radiological evaluations (which must include either CT scans of the chest/abdomen/pelvis or a CT of the chest and a MRI of the abdomen/pelvis) must be performed within 4 weeks prior to the start of study therapy. * Informed Consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts. * Non pregnant females who are not breast feeding with a negative serum β-HCG test within 1 week of starting the study. Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for 6 months after completion of treatment. They must understand the risks of infertility possibly associated with adjuvant treatment. * Clinical Parameters: * Age ≥ 18 to ≤ 75 years old * Performance status 0-2 (ECOG) * Peripheral Neuropathy must be \< grade 1 * Able to tolerate oral medications * Absolute Neutrophil Count \> 1,500 ul * White Blood Count \> 3,000/ul * Platelet count \> 100,000/ul * BUN \< 1.5 x ULN * Creatinine \< 1.5 x ULN * Hemoglobin \> 8.0 g/dl * Serum Albumin \> 2.5 mg/dl * Total Bilirubin \< 3.0 mg/dl * AST ≤4.0 x ULN * ALT ≤4.0 x ULN * Alkaline Phosphatase ≤4.0 x ULN\] * CA 19-9 should be normal post surgery. Can still be put on protocol with elevation if clinically significant for inflammation or infection, not cancer Exclusion Criteria: * Prior chemotherapy for their pancreatic cancer or radiation to the area of the tumor. * Prior malignancies in last 5 years other than curatively treated carcinoma in-situ of any site in the body. * Serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection). * Patients with compromised immune systems are at increased risk of toxicity and lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients are excluded from the study. * Any prior investigational agent/therapy or any investigational agent/therapy while on protocol. * Hypersensitivity: Patients with a history of severe hypersensitivity reaction to Taxotere® or other drug formulated with polysorbate 80 will be excluded.
References
Publications (0)
Data not yet available