Trial Outcomes & Findings for Phase II Study of Oxaliplatin, Irinotecan, and Capecitabine in Advanced Gastric/Gastroesophageal Junction Carcinoma (NCT NCT00084617)

Last Updated: 2015-05-01

Results Overview

Response is defined as the number of patients with a CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of the target lesions or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage or increase of target lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

at 12 weeks (after 2 cycles of treatment)

Results posted on

2015-05-01

Participant Flow

This was a multi-center single treatment arm study involving four sites. Patients were recruited February 2004 through February 2007.

Participant milestones

Participant milestones
Measure	Treatment (Oxaliplatin, Irinotecan, Capecitabine) Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	39
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Oxaliplatin, Irinotecan, Capecitabine) Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Overall Study Withdrawal by Subject	7
Overall Study Lack of Efficacy	1
Overall Study Protocol Violation	1

Baseline Characteristics

Phase II Study of Oxaliplatin, Irinotecan, and Capecitabine in Advanced Gastric/Gastroesophageal Junction Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Oxaliplatin, Irinotecan, Capecitabine) n=39 Participants Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Age, Continuous	57.8 years n=39 Participants
Sex: Female, Male Female	10 Participants n=39 Participants
Sex: Female, Male Male	29 Participants n=39 Participants
Region of Enrollment United States	39 participants n=39 Participants

PRIMARY outcome

Timeframe: at 12 weeks (after 2 cycles of treatment)

Population: Patients that completed at least 2 cycles of treatment

Outcome measures

Outcome measures
Measure	Treatment (Oxaliplatin, Irinotecan, Capecitabine) n=30 Participants Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Response Rates (RR) in Metastatic Gastric/GE Junction Tumors Complete Response (CR)	2 participants
Response Rates (RR) in Metastatic Gastric/GE Junction Tumors Partial Response (PR)	9 participants
Response Rates (RR) in Metastatic Gastric/GE Junction Tumors Progressive Disease (PD)	3 participants
Response Rates (RR) in Metastatic Gastric/GE Junction Tumors Stable Disease (SD)	16 participants

SECONDARY outcome

Timeframe: at 40 months from study activation

Population: Patients that achieved either a CR or PR.

The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).

Outcome measures

Outcome measures
Measure	Treatment (Oxaliplatin, Irinotecan, Capecitabine) n=11 Participants Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Complete Response (CR) and Partial Response (PR) Duration	5.95 months Interval 2.07 to 10.55

SECONDARY outcome

Timeframe: at 40 months from study activation

Population: All patients enrolled in study

Length of time patients survived after treatment

Outcome measures

Outcome measures
Measure	Treatment (Oxaliplatin, Irinotecan, Capecitabine) n=39 Participants Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Overall Survival	8.98 months Interval 6.85 to 13.31

Adverse Events

Treatment (Oxaliplatin, Irinotecan, Capecitabine)

Serious events: 7 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Oxaliplatin, Irinotecan, Capecitabine) n=39 participants at risk Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Vascular disorders Thrombosis/thrombus/embolism	2.6% 1/39 • Adverse events were assessed while patients were on study for up to 4 years
General disorders Death not associated with CTCAE term - Disease progression NOS	2.6% 1/39 • Adverse events were assessed while patients were on study for up to 4 years
Nervous system disorders Seizure	2.6% 1/39 • Adverse events were assessed while patients were on study for up to 4 years
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory	2.6% 1/39 • Adverse events were assessed while patients were on study for up to 4 years
Gastrointestinal disorders Perforation, GI - Esophagus	2.6% 1/39 • Adverse events were assessed while patients were on study for up to 4 years
Vascular disorders Hypotension	2.6% 1/39 • Adverse events were assessed while patients were on study for up to 4 years
Metabolism and nutrition disorders Dehydration	2.6% 1/39 • Adverse events were assessed while patients were on study for up to 4 years
Renal and urinary disorders Renal failure	2.6% 1/39 • Adverse events were assessed while patients were on study for up to 4 years
Gastrointestinal disorders Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)	2.6% 1/39 • Adverse events were assessed while patients were on study for up to 4 years
Gastrointestinal disorders Hemorrhage, GI - Esophagus	2.6% 1/39 • Adverse events were assessed while patients were on study for up to 4 years
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	2.6% 1/39 • Adverse events were assessed while patients were on study for up to 4 years

Other adverse events

Other adverse events
Measure	Treatment (Oxaliplatin, Irinotecan, Capecitabine) n=39 participants at risk Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Albumin, serum-low (hypoalbuminemia)	61.5% 24/39 • Adverse events were assessed while patients were on study for up to 4 years
Investigations Alkaline phosphatase	46.2% 18/39 • Adverse events were assessed while patients were on study for up to 4 years
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	10.3% 4/39 • Adverse events were assessed while patients were on study for up to 4 years
Metabolism and nutrition disorders Anorexia	53.8% 21/39 • Adverse events were assessed while patients were on study for up to 4 years
Investigations AST, SGOT(serum glutamic oxaloacetic transaminase)	15.4% 6/39 • Adverse events were assessed while patients were on study for up to 4 years
Metabolism and nutrition disorders Bicarbonate, serum-low	10.3% 4/39 • Adverse events were assessed while patients were on study for up to 4 years
Metabolism and nutrition disorders Calcium, serum-high (hypercalcemia)	5.1% 2/39 • Adverse events were assessed while patients were on study for up to 4 years
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	43.6% 17/39 • Adverse events were assessed while patients were on study for up to 4 years
Gastrointestinal disorders Constipation	30.8% 12/39 • Adverse events were assessed while patients were on study for up to 4 years
Respiratory, thoracic and mediastinal disorders Cough	20.5% 8/39 • Adverse events were assessed while patients were on study for up to 4 years
Metabolism and nutrition disorders Dehydration	30.8% 12/39 • Adverse events were assessed while patients were on study for up to 4 years
Gastrointestinal disorders Diarrhea	74.4% 29/39 • Adverse events were assessed while patients were on study for up to 4 years
Gastrointestinal disorders Distension/bloating, abdominal	10.3% 4/39 • Adverse events were assessed while patients were on study for up to 4 years
Nervous system disorders Dizziness	25.6% 10/39 • Adverse events were assessed while patients were on study for up to 4 years
Skin and subcutaneous tissue disorders Dry skin	5.1% 2/39 • Adverse events were assessed while patients were on study for up to 4 years
Gastrointestinal disorders Dysphagia (difficulty swallowing)	25.6% 10/39 • Adverse events were assessed while patients were on study for up to 4 years
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	23.1% 9/39 • Adverse events were assessed while patients were on study for up to 4 years
General disorders Edema: limb	15.4% 6/39 • Adverse events were assessed while patients were on study for up to 4 years
Gastrointestinal disorders Esophagitis	5.1% 2/39 • Adverse events were assessed while patients were on study for up to 4 years
General disorders Fatigue (asthenia, lethargy, malaise)	74.4% 29/39 • Adverse events were assessed while patients were on study for up to 4 years
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	7.7% 3/39 • Adverse events were assessed while patients were on study for up to 4 years
Gastrointestinal disorders Flatulence	12.8% 5/39 • Adverse events were assessed while patients were on study for up to 4 years
Vascular disorders Flushing	7.7% 3/39 • Adverse events were assessed while patients were on study for up to 4 years
Investigations GGT (gamma-Glutamyl transpeptidase)	10.3% 4/39 • Adverse events were assessed while patients were on study for up to 4 years
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	53.8% 21/39 • Adverse events were assessed while patients were on study for up to 4 years
Metabolism and nutrition disorders Glucose, serum-low (hypoglycemia)	12.8% 5/39 • Adverse events were assessed while patients were on study for up to 4 years
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	10.3% 4/39 • Adverse events were assessed while patients were on study for up to 4 years
Gastrointestinal disorders Heartburn/dyspepsia	10.3% 4/39 • Adverse events were assessed while patients were on study for up to 4 years
Investigations Hemoglobin	64.1% 25/39 • Adverse events were assessed while patients were on study for up to 4 years
Respiratory, thoracic and mediastinal disorders Hiccoughs (hiccups, singultus)	5.1% 2/39 • Adverse events were assessed while patients were on study for up to 4 years
Vascular disorders Hot flashes/flushes	15.4% 6/39 • Adverse events were assessed while patients were on study for up to 4 years
Vascular disorders Hypertension	5.1% 2/39 • Adverse events were assessed while patients were on study for up to 4 years
Vascular disorders Hypotension	7.7% 3/39 • Adverse events were assessed while patients were on study for up to 4 years
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Neck NOS	10.3% 4/39 • Adverse events were assessed while patients were on study for up to 4 years
Infections and infestations Infection with unknown ANC	10.3% 4/39 • Adverse events were assessed while patients were on study for up to 4 years
Blood and lymphatic system disorders INR (International Normalized Ratio of prothrombin time)	5.1% 2/39 • Adverse events were assessed while patients were on study for up to 4 years
Psychiatric disorders Insomnia	28.2% 11/39 • Adverse events were assessed while patients were on study for up to 4 years
Blood and lymphatic system disorders Leukocytes (total WBC)	46.2% 18/39 • Adverse events were assessed while patients were on study for up to 4 years
Blood and lymphatic system disorders Lymphopenia	38.5% 15/39 • Adverse events were assessed while patients were on study for up to 4 years
Metabolism and nutrition disorders Magnesium, serum-high (hypermagnesemia)	5.1% 2/39 • Adverse events were assessed while patients were on study for up to 4 years
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	17.9% 7/39 • Adverse events were assessed while patients were on study for up to 4 years
Psychiatric disorders Mood alteration - Agitation	5.1% 2/39 • Adverse events were assessed while patients were on study for up to 4 years
Psychiatric disorders Mood alteration - Depression	10.3% 4/39 • Adverse events were assessed while patients were on study for up to 4 years
Gastrointestinal disorders Mucositis/stomatitis	17.9% 7/39 • Adverse events were assessed while patients were on study for up to 4 years
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy)	25.6% 10/39 • Adverse events were assessed while patients were on study for up to 4 years
Gastrointestinal disorders Nausea	51.3% 20/39 • Adverse events were assessed while patients were on study for up to 4 years
Nervous system disorders Neuropathy: sensory	53.8% 21/39 • Adverse events were assessed while patients were on study for up to 4 years
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	35.9% 14/39 • Adverse events were assessed while patients were on study for up to 4 years
Gastrointestinal disorders Pain - Abdomen NOS	48.7% 19/39 • Adverse events were assessed while patients were on study for up to 4 years
Musculoskeletal and connective tissue disorders Pain - Back	23.1% 9/39 • Adverse events were assessed while patients were on study for up to 4 years
Musculoskeletal and connective tissue disorders Pain - Chest wall	12.8% 5/39 • Adverse events were assessed while patients were on study for up to 4 years
Musculoskeletal and connective tissue disorders Pain - Chest/thorax NOS	7.7% 3/39 • Adverse events were assessed while patients were on study for up to 4 years
Musculoskeletal and connective tissue disorders Pain - Extremity-limb	5.1% 2/39 • Adverse events were assessed while patients were on study for up to 4 years
Nervous system disorders Pain - Head/headache	7.7% 3/39 • Adverse events were assessed while patients were on study for up to 4 years
General disorders Pain - Pain NOS	10.3% 4/39 • Adverse events were assessed while patients were on study for up to 4 years
Cardiac disorders Palpitations	5.1% 2/39 • Adverse events were assessed while patients were on study for up to 4 years
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	7.7% 3/39 • Adverse events were assessed while patients were on study for up to 4 years
Blood and lymphatic system disorders Platelets	35.9% 14/39 • Adverse events were assessed while patients were on study for up to 4 years
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	7.7% 3/39 • Adverse events were assessed while patients were on study for up to 4 years
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	15.4% 6/39 • Adverse events were assessed while patients were on study for up to 4 years
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	41.0% 16/39 • Adverse events were assessed while patients were on study for up to 4 years
Renal and urinary disorders Proteinuria	7.7% 3/39 • Adverse events were assessed while patients were on study for up to 4 years
Blood and lymphatic system disorders PTT (Partial Thromboplastin Time)	7.7% 3/39 • Adverse events were assessed while patients were on study for up to 4 years
Skin and subcutaneous tissue disorders Rash/desquamation	5.1% 2/39 • Adverse events were assessed while patients were on study for up to 4 years
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	5.1% 2/39 • Adverse events were assessed while patients were on study for up to 4 years
General disorders Rigors/chills	5.1% 2/39 • Adverse events were assessed while patients were on study for up to 4 years
Metabolism and nutrition disorders Sodium, serum-high (hypernatremia)	7.7% 3/39 • Adverse events were assessed while patients were on study for up to 4 years
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	28.2% 11/39 • Adverse events were assessed while patients were on study for up to 4 years
Cardiac disorders Supraventricular and nodal arrhythmia	12.8% 5/39 • Adverse events were assessed while patients were on study for up to 4 years
Vascular disorders Sweating (diaphoresis)	7.7% 3/39 • Adverse events were assessed while patients were on study for up to 4 years
Nervous system disorders Taste alteration (dysgeusia)	10.3% 4/39 • Adverse events were assessed while patients were on study for up to 4 years
Renal and urinary disorders Urinary frequency/urgency	7.7% 3/39 • Adverse events were assessed while patients were on study for up to 4 years
Eye disorders Vision-blurred vision	5.1% 2/39 • Adverse events were assessed while patients were on study for up to 4 years
Gastrointestinal disorders Vomiting	30.8% 12/39 • Adverse events were assessed while patients were on study for up to 4 years
Investigations Weight gain	7.7% 3/39 • Adverse events were assessed while patients were on study for up to 4 years
Investigations Weight loss	48.7% 19/39 • Adverse events were assessed while patients were on study for up to 4 years

Additional Information

Joanna Brell MD

National Cancer Institute

Phone: 240-276-7050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60