Cancer
Conditions
Keywords
gastric, stomach, esophagus, esophageal
Brief summary
This is a phase II study that will investigate weekly dosing of docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas.
Detailed description
This is a phase II study that will investigate weekly dosing of docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas. Docetaxel 30mg/m2 will be administered on days 1 and 8 of each cycle and capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14) of each cycle. Each cycle is 21 days. Subjects will receive unlimited cycles of docetaxel and capecitabine until there is evidence of disease progression or unacceptable side effects.
Interventions
DRUGDocetaxel
Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Cycle 2 will begin on day 22.
DRUGCapecitabine
Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14). Each cycle will consist of 21 days. Cycle 2 will begin on day 22.
Sponsors
Aventis Pharmaceuticals
Roche Pharma AG
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have histologically or cytologically confirmed locally advanced (unresectable) or metastatic adenocarcinoma of gastric, gastro-esophageal, or esophageal origin. 2. Must have measurable or evaluable disease. 3. Received adjuvant therapy are eligible if adjuvant therapy was given ≥ 6 months prior to the diagnosis of metastatic disease. 4. Life expectancy greater than 12 weeks. 5. ECOG performance status \< 2. 6. Adequate organ and marrow function. 7. Preexisting peripheral neuropathy if present must be grade 0 or 1. 8. Women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 3 months thereafter. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential
Exclusion criteria
1. No chemotherapy or radiotherapy within 4 weeks 2. Not receiving any other investigational agents or participate in any investigational drug study within 4 weeks preceding the start of study treatment. 3. Patients with known brain metastases shall be excluded from this clinical trial 4. Patients with evidence or history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant that precludes informed consent or interferes with the compliance of oral drug intake will also be excluded. 5. History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80. 6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel, capecitabine or 5-FU. 7. Uncontrolled intercurrent illness 8. Pregnant or breast feeding women are excluded from this study 9. Inability to swallow tablets or those who have malabsorptive symptoms will be excluded. 10. HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with docetaxel or capecitabine. 11. Prior use of docetaxel or capecitabine is not allowed ( Prior 5FU therapy is allowed). 12. Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer. 13. Major surgery ( i.e laparotomy, line placement is not considered major surgery)within 4 weeks of the start of study treatment, without complete recovery. 14. Known, existing uncontrolled coagulopathy. 15. Patients on anticonvulsants that are metabolized via P450 3A4 pathway.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 2 years | The time interval between the date on which a patient first received protocol treatment and the documented date of death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | Every 2 cycles (6 weeks) | The number of responders (complete responders + partial responders) divided by the number of evaluable patients. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Docetaxel + Capecitabine Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.
Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days. Cycle 2 will begin on day 22.
Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.
Cycle 2 will begin on day 22.
Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days.
Cycle 2 will begin on day 22. | 39 |
| Total | 39 |
Baseline characteristics
| Characteristic | Docetaxel + Capecitabine |
|---|---|
| Age, Continuous | 61 years |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 37 / 39 |
| serious Total, serious adverse events | 20 / 39 |
Outcome results
Primary
Overall Survival
The time interval between the date on which a patient first received protocol treatment and the documented date of death.
Time frame: 2 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Docetaxel + Capecitabine | Overall Survival | 10.7 Months |
Secondary
Overall Response Rate
The number of responders (complete responders + partial responders) divided by the number of evaluable patients.
Time frame: Every 2 cycles (6 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Docetaxel + Capecitabine | Overall Response Rate | 28.2 percentage of participants |