Trial Outcomes & Findings for Sorafenib, Docetaxel, and Cisplatin in Treating Patients With Metastatic or Advanced Gastric or Gastroesophageal Junction Cancer (NCT NCT00253370)
NCT ID: NCT00253370
Last Updated: 2014-11-24
Results Overview
Response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= \>=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Assessed every 6 weeks until disease progression or up to 3 years
Results posted on
2014-11-24
Participant Flow
Participants were recruited from ECOG member institutions between October 28, 2005 and July 2, 2007. The final accrual was 44 patients.
Participant milestones
| Measure |
BAY 43-9006, Docetaxel, Cisplatin
Patients receive oral BAY 43-9006 400 mg twice daily on days 1-21. Patients also receive docetaxel IV, 75mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
BAY 43-9006: Given orally
docetaxel: Given IV
cisplatin: Given IV
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
43
|
Reasons for withdrawal
| Measure |
BAY 43-9006, Docetaxel, Cisplatin
Patients receive oral BAY 43-9006 400 mg twice daily on days 1-21. Patients also receive docetaxel IV, 75mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
BAY 43-9006: Given orally
docetaxel: Given IV
cisplatin: Given IV
|
|---|---|
|
Overall Study
Adverse Event
|
18
|
|
Overall Study
Disease progression
|
13
|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Non-protocol therapy
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Abdominal pain due to disease
|
1
|
Baseline Characteristics
Sorafenib, Docetaxel, and Cisplatin in Treating Patients With Metastatic or Advanced Gastric or Gastroesophageal Junction Cancer
Baseline characteristics by cohort
| Measure |
BAY 43-9006, Docetaxel, Cisplatin
n=44 Participants
Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
BAY 43-9006: Given orally
docetaxel: Given IV
cisplatin: Given IV
|
|---|---|
|
Age, Continuous
|
58.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed every 6 weeks until disease progression or up to 3 yearsPopulation: All enrolled patients started treatment and were considered eligible and hence were all included in the analysis.
Response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= \>=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.
Outcome measures
| Measure |
BAY 43-9006, Docetaxel, Cisplatin
n=44 Participants
Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV, 75 mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
BAY 43-9006: Given orally
docetaxel: Given IV
cisplatin: Given IV
|
|---|---|
|
The Proportion of Patients With Objective Response (Complete Response or Partial Response)
|
0.409 Proportion of patients
Interval 0.284 to 0.544
|
SECONDARY outcome
Timeframe: Assessed every 6 weeks until disease progression or up to 3 yearsPopulation: All enrolled patients started treatment and were considered eligible and hence were all included in the analysis.
Progression-free survival was defined as the shorter of: 1. The time from registration to progression. or 2. The time from registration to death without documentation of progression given that the death occurs within 4 months of the last disease assessment without progression (or registration, whichever is more recent). Therefore, cases not meeting either of the criteria for a PFS event are censored at the date of last disease assessment without progression (or registration, whichever is more recent). Progression is defined as at least 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
BAY 43-9006, Docetaxel, Cisplatin
n=44 Participants
Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV, 75 mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
BAY 43-9006: Given orally
docetaxel: Given IV
cisplatin: Given IV
|
|---|---|
|
Progression-free Survival (PFS)
|
5.8 Months
Interval 5.4 to 7.4
|
SECONDARY outcome
Timeframe: Assessed every 3 months if patient is < 2 years from study entry; then every 6 months if patient is 2-3 years from study entry.Population: All enrolled patients started treatment and were considered eligible and hence were all included in the analysis.
Overall survival was defined as the time from registration to death from any cause.
Outcome measures
| Measure |
BAY 43-9006, Docetaxel, Cisplatin
n=44 Participants
Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV, 75 mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
BAY 43-9006: Given orally
docetaxel: Given IV
cisplatin: Given IV
|
|---|---|
|
Overall Survival (OS)
|
13.6 Months
Interval 8.6 to 16.1
|
Adverse Events
BAY 43-9006, Docetaxel, Cisplatin
Serious events: 40 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BAY 43-9006, Docetaxel, Cisplatin
n=44 participants at risk
Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
BAY 43-9006: Given orally
docetaxel: Given IV
cisplatin: Given IV
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
15.9%
7/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Stenosis (incl anastomotic) esophagus
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
4/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Esophagus, hemorrhage
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hemorrhage-other
|
4.5%
2/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.1%
4/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr3-4 neut, catheter relate
|
4.5%
2/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr3-4 neut, urinary tract
|
4.5%
2/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, foreign body
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr3-4 neut, blood
|
4.5%
2/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, blood
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.5%
2/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
4.5%
2/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
4.5%
2/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Blood bilirubin increased
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.5%
2/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.8%
3/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.5%
2/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.1%
4/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.4%
5/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Ataxia
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Confusion
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-sensory
|
9.1%
4/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Seizure
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Syncope
|
6.8%
3/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Esophagus, pain
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Head/headache
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Scalp, pain
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Renal failure
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Urinary retention
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
6.8%
3/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Immune system disorders
Allergic reaction
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Leukocytes decreased
|
40.9%
18/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphopenia
|
4.5%
2/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophils decreased
|
63.6%
28/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelets decreased
|
4.5%
2/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Atrial fibrillation
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypotension
|
4.5%
2/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
15.9%
7/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
9.1%
4/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
22.7%
10/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
13.6%
6/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
20.5%
9/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
13.6%
6/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Fistula, Rectum
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
2.3%
1/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
Other adverse events
| Measure |
BAY 43-9006, Docetaxel, Cisplatin
n=44 participants at risk
Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
BAY 43-9006: Given orally
docetaxel: Given IV
cisplatin: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
75.0%
33/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Leukocytes decreased
|
43.2%
19/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphopenia
|
6.8%
3/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophils decreased
|
36.4%
16/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelets decreased
|
45.5%
20/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypertension
|
13.6%
6/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
90.9%
40/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fever w/o neutropenia
|
20.5%
9/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Insomnia
|
6.8%
3/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
27.3%
12/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.4%
5/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
65.9%
29/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
13.6%
6/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
11.4%
5/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
27.3%
12/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
22.7%
10/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
43.2%
19/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
43.2%
19/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
15.9%
7/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
20.5%
9/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
45.5%
20/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
40.9%
18/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
65.9%
29/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Taste disturbance
|
20.5%
9/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
56.8%
25/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Edema limb
|
11.4%
5/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
31.8%
14/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
11/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
22.7%
10/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
11/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Blood bilirubin increased
|
13.6%
6/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.4%
5/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
27.3%
12/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
40.9%
18/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.8%
3/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.8%
3/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
18.2%
8/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
18.2%
8/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-sensory
|
40.9%
18/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Eye disorders
Tearing
|
9.1%
4/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdomen, pain
|
6.8%
3/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
9.1%
4/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Head/headache
|
11.4%
5/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
13.6%
6/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
4/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.4%
5/44 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60