Trial Outcomes & Findings for Bryostatin 1 and Cisplatin in Treating Patients With Metastatic or Unresectable Stomach Cancer (NCT NCT00006389)

Last Updated: 2014-10-01

Results Overview

All patients had measurable disease and were assessed after 2 cycles of chemotherapy by medical photograph, plain x-ray, CT, MRI or other imaging scans of at least 2.0 cm or greater with conventional techniques or 1.0 cm or greater with spiral CT. Patients were evaluated by RECIST criteria. All measurable lesions, up to 10 "target lesions" were recorded and measured at baseline across the longest diameter (LD). All other non-target lesions were documented as present or absent. Complete Response (CR) was defined as complete disappearance of the tumor, partial response (PR) was defined as at least a 30% decrease of the sum of the LD of the target lesions, using the baseline sum LD as the reference The observed response rate was defined as the percentage of evaluable patients whose best response is a CR or PR with associated 95% confidence interval.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Best response recorded from the start of treatment until disease progression/recurrence. Assessed every 2 cycles.

Results posted on

2014-10-01

Participant Flow

From October 2000 through March 2002, a total of 12 patients signed a consent form and were enrolled on this study: 2 from COH, 8 from USC and 2 from UCD. All patients received treatment.

Participant milestones

Participant milestones
Measure	Treatment Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. bryostatin 1: Given IV cisplatin: Given IV laboratory biomarker analysis: Correlative studies
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. bryostatin 1: Given IV cisplatin: Given IV laboratory biomarker analysis: Correlative studies
Overall Study Adverse Event	1

Baseline Characteristics

Bryostatin 1 and Cisplatin in Treating Patients With Metastatic or Unresectable Stomach Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=12 Participants Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. bryostatin 1: Given IV cisplatin: Given IV laboratory biomarker analysis: Correlative studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Best response recorded from the start of treatment until disease progression/recurrence. Assessed every 2 cycles.

Population: The first 15 patients accrued to an Optimal Three-Stage Phase II design. If 3 or more responses are seen then 18 additional evaluable patients will be accrued to the second stage.

Outcome measures

Outcome measures
Measure	Treatment n=12 Participants Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. bryostatin 1: Given IV cisplatin: Given IV laboratory biomarker analysis: Correlative studies
Observed Response Rate.	0 Percentage of Participants Interval 0.0 to 26.5

SECONDARY outcome

Timeframe: 18 months

Overall survival was estimated according to the Kaplan-Meier product-limit method.

Outcome measures

Outcome measures
Measure	Treatment n=12 Participants Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. bryostatin 1: Given IV cisplatin: Given IV laboratory biomarker analysis: Correlative studies
Overall Survival	2.7 Months Interval 1.6 to 5.3

SECONDARY outcome

Timeframe: 18 months

Progression-free survival was estimated according to the Kaplan-Meier product-limit method

Outcome measures

Outcome measures
Measure	Treatment n=12 Participants Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. bryostatin 1: Given IV cisplatin: Given IV laboratory biomarker analysis: Correlative studies
Progression-free Survival	1.2 months Interval 1.0 to 2.2

Adverse Events

Treatment

Serious events: 5 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=12 participants at risk Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. bryostatin 1: Given IV cisplatin: Given IV laboratory biomarker analysis: Correlative studies
Blood and lymphatic system disorders Hemoglobin	16.7% 2/12 • Number of events 2 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Blood and lymphatic system disorders Transfusion: pRBCs	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Cardiac disorders Supraventricular and nodal arrhythmia	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Gastrointestinal disorders Esophagitis	16.7% 2/12 • Number of events 2 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Gastrointestinal disorders Nausea	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Gastrointestinal disorders Vomiting	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Investigations AST, SGOT(serum glutamic oxaloacetic transaminase)	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Investigations Bilirubin (hyperbilirubinemia)	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Metabolism and nutrition disorders Anorexia	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Respiratory, thoracic and mediastinal disorders Hypoxia	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Vascular disorders Hypotension	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.

Other adverse events

Other adverse events
Measure	Treatment n=12 participants at risk Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. bryostatin 1: Given IV cisplatin: Given IV laboratory biomarker analysis: Correlative studies
Blood and lymphatic system disorders Hemoglobin	83.3% 10/12 • Number of events 20 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Blood and lymphatic system disorders Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Blood and lymphatic system disorders Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia	16.7% 2/12 • Number of events 2 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Blood and lymphatic system disorders Transfusion: pRBCs	16.7% 2/12 • Number of events 2 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Cardiac disorders Palpitations	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Cardiac disorders Supraventricular and nodal arrhythmia	33.3% 4/12 • Number of events 4 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Gastrointestinal disorders Constipation	33.3% 4/12 • Number of events 7 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Gastrointestinal disorders Diarrhea	25.0% 3/12 • Number of events 3 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Gastrointestinal disorders Diarrhea patients with a colostomy	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Gastrointestinal disorders Esophagitis	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Gastrointestinal disorders Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic)	16.7% 2/12 • Number of events 3 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Gastrointestinal disorders Nausea	66.7% 8/12 • Number of events 15 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Gastrointestinal disorders Vomiting	66.7% 8/12 • Number of events 12 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
General disorders Constitutional Symptoms - Other (Specify, __)	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
General disorders Edema	41.7% 5/12 • Number of events 6 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
General disorders Fatigue (asthenia, lethargy, malaise)	75.0% 9/12 • Number of events 17 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	16.7% 2/12 • Number of events 2 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
General disorders Rigors/chills	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Infections and infestations Infection - Other (Specify, __)	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Infections and infestations Infection without neutropenia	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	25.0% 3/12 • Number of events 4 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Investigations AST, SGOT(serum glutamic oxaloacetic transaminase)	33.3% 4/12 • Number of events 6 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Investigations Alkaline phosphatase	50.0% 6/12 • Number of events 8 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Investigations Bilirubin (hyperbilirubinemia)	16.7% 2/12 • Number of events 2 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Investigations Cholesterol, serum-high (hypercholesteremia)	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Investigations Creatinine	25.0% 3/12 • Number of events 5 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Investigations FEV(1)	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Investigations INR (International Normalized Ratio of prothrombin time)	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Investigations Leukocytes (total WBC)	33.3% 4/12 • Number of events 7 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Investigations Lymphopenia	66.7% 8/12 • Number of events 14 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Investigations Neutrophils/granulocytes (ANC/AGC) for leukemia studies or bm infiltrative/myelophthisic	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Investigations Platelets	33.3% 4/12 • Number of events 9 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Investigations Weight loss	25.0% 3/12 • Number of events 3 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	58.3% 7/12 • Number of events 11 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Metabolism and nutrition disorders Anorexia	50.0% 6/12 • Number of events 7 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	58.3% 7/12 • Number of events 10 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Metabolism and nutrition disorders Dehydration	16.7% 2/12 • Number of events 3 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	75.0% 9/12 • Number of events 15 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Metabolism and nutrition disorders Magnesium, serum-high (hypermagnesemia)	16.7% 2/12 • Number of events 2 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	33.3% 4/12 • Number of events 6 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	25.0% 3/12 • Number of events 3 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	25.0% 3/12 • Number of events 3 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	16.7% 2/12 • Number of events 2 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Metabolism and nutrition disorders Sodium, serum-high (hypernatremia)	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	75.0% 9/12 • Number of events 10 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Nervous system disorders Dizziness	8.3% 1/12 • Number of events 2 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Nervous system disorders Neuropathy: motor	25.0% 3/12 • Number of events 5 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Nervous system disorders Neuropathy: sensory	16.7% 2/12 • Number of events 2 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Nervous system disorders Pain	75.0% 9/12 • Number of events 29 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Psychiatric disorders Confusion	8.3% 1/12 • Number of events 2 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Psychiatric disorders Insomnia	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Psychiatric disorders Mood alteration	25.0% 3/12 • Number of events 3 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Renal and urinary disorders Obstruction, GU	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Renal and urinary disorders Urinary frequency/urgency	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 3/12 • Number of events 3 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	33.3% 4/12 • Number of events 5 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Skin and subcutaneous tissue disorders Dry skin	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Skin and subcutaneous tissue disorders Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Skin and subcutaneous tissue disorders Pruritus/itching	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Skin and subcutaneous tissue disorders Rash/desquamation	16.7% 2/12 • Number of events 2 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Vascular disorders Hypertension	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.
Vascular disorders Hypotension	8.3% 1/12 • Number of events 1 • 1 year, 5 months All adverse events (all grades \& attributions) that were not identified as serious are included in "Other" events table.

Additional Information

DCC Project Administrator

California Cancer Consortium

Phone: 626-256-4673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60