A Phase 1 interventional study of Capecitabine and Docetaxel in Pancreatic Cancer, sponsored by Tony Bekaii-Saab. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-27.
Sponsored by Tony Bekaii-Saab · Phase 1, Interventional, and Treatment
The primary purpose of this study is to define the maximum tolerated dose of combination docetaxel, gemcitabine, and capecitabine in patients with pancreatic cancer. Adverse effects will be measured in study participants. In addition, researchers will assess data about preliminary efficacy in patients with this treatment approach.
Rationale: Single agent gemcitabine is considered standard care for patients with advanced pancreatic cancer. However, better treatments offering improved outcomes are needed for people with this disease. The combination of docetaxel and capecitabine has shown significant and broad clinical activity in a variety of tumors. Laboratory research on the combination of capecitabine, docetaxel, and gemcitabine indicates synergistic action against tumor cells. The current study will test this combination in patients. The drug administration schedule in this study is aimed at maximizing the potential of activation of capecitabine by both docetaxel and gemcitabine.
Treatment: Study participants will be given docetaxel, gemcitabine, and capecitabine. All study drugs will be administered through intravenous infusions in three week cycles. Docetaxel will be given on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. This schedule will be followed by 1 week of rest without administration of study drugs. Since the primary goal of this study is to identify the maximum tolerated dose of the study drugs in combination, patients who enroll in the beginning of the study will receive lower amounts of the study drugs compared to patients who enroll later in the study. Several tests and exams will be given throughout the study to closely monitor patients.
3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.
This study's enrollment of 21 is below the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.
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Exclusion Criteria:
Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capcitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.
Drug: Capecitabine · Drug: Docetaxel · Drug: Gemcitabine
Will be give on days 8-21
Also known as: Xeloda
Will be given on days 1 and 8,
Also known as: Taxotere
A fixed dose rate will be give on days 8 and 15.
Also known as: Gemzar
Maximum Tolerated Dose (MTD)
MTD will be the dose at which 1 or fewer patients (≤ 1/6) experiences a DLT during the first or second cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing Dose Limiting Toxicities (DLT).
Time frame: Weekly up to 24 weeks
Common Toxicities
The NCI Common Terminology Criteria for Adverse Events version 3.0 was used for adverse event reporting and toxicity grading.
Time frame: Weekly up to 24 weeks
Therapeutic Response
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: every 8 weeks, up to 24 weeks
Patients were enrolled into the study between December 2005 and February 2008.
| Milestone | Dose Level 1 | Dose Level 2 | Dose Level 3 |
|---|---|---|---|
| Started | 3 | 8 | 10 |
| Completed | 3 | 6 | 1 |
| Not completed | 0 | 2 | 9 |
MTD will be the dose at which 1 or fewer patients (≤ 1/6) experiences a DLT during the first or second cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing Dose Limiting Toxicities (DLT).
| mg/m^2 | Capecitabine, Docetaxel, Gemcitabine |
|---|---|
| docetaxel | 36 |
| gemcitabine | 750 |
| capecitabine | 625 |
The NCI Common Terminology Criteria for Adverse Events version 3.0 was used for adverse event reporting and toxicity grading.
| percent of patients | Capecitabine, Docetaxel, Gemcitabine |
|---|---|
| leukopenia | 29 |
| neutropenia | 29 |
| fatigue | 25 |
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| percent of patients | Capecitabine, Docetaxel, Gemcitabine |
|---|---|
| Partial Response | 11 |
| Complete Response | 0 |
| Stable Disease | 72 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Capecitabine, Docetaxel, Gemcitabine | — | 0/21 (0%) | 21/21 (100%) |
| Event | Capecitabine, Docetaxel, Gemcitabine |
|---|---|
| FatigueGeneral disorders | 18/21 |
| NauseaGastrointestinal disorders | 16/21 |
| DiarrheaGastrointestinal disorders | 16/21 |
| LeukopeniaBlood and lymphatic system disorders | 14/21 |
| AlopeciaSkin and subcutaneous tissue disorders | 13/21 |
| NeutropeniaBlood and lymphatic system disorders | 11/21 |
| NeuropathyNervous system disorders | 11/21 |
| AnemiaBlood and lymphatic system disorders | 10/21 |
| ThrombocytopeniaInjury, poisoning and procedural complications | 10/21 |
| VomitingGastrointestinal disorders | 8/21 |
| Age, Continuous(years) | Capecitabine, Gemcitabine and Docetaxel |
|---|---|
| Mean | 59 (48 to 72) |
| Sex: Female, Male(Participants) | Capecitabine, Gemcitabine and Docetaxel |
|---|---|
| Female | 13 |
| Male | 8 |
| Region of Enrollment(participants) | Capecitabine, Gemcitabine and Docetaxel |
|---|---|
| United States | 21 |
| Eastern Cooperative Oncology Group (ECOG)(patients) | Capecitabine, Gemcitabine and Docetaxel |
|---|---|
| ECOG 0 (Fully Active) | 4 |
| ECOG 1 (Restricted physical activity) | 17 |
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Capecitabine · Docetaxel · Gemcitabine
Tony Bekaii-Saab