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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02361 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CHNMC-PHII-22 | |||
| CDR0000068267 | |||
| NCI-T99-0040 | |||
| PHII-22 (USC 3S-00-1) | Other Identifier | University of Southern California | |
| T99-0040 | Other Identifier | CTEP | |
| N01CM17101 | U.S. NIH Grant/Contract | View source |
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Phase II trial to study the effectiveness of bryostatin 1 and cisplatin in treating patients who have metastatic or unresectable stomach cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bryostatin 1 may increase the effectiveness of cisplatin by making tumor cells more sensitive to the drug. Combining cisplatin with bryostatin 1 may kill more tumor cells.
OBJECTIVES:
I. Determine the response rate and survival in patients with metastatic or unresectable carcinoma of the stomach treated with bryostatin 1 and cisplatin.
II. Determine the toxic effects of this regimen in these patients. III. Determine the molecular determinants of response to this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bryostatin 1 | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Observed Response Rate. | 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. | Best response recorded from the start of treatment until disease progression/recurrence. Assessed every 2 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival was estimated according to the Kaplan-Meier product-limit method. | 18 months |
| Progression-free Survival | Progression-free survival was estimated according to the Kaplan-Meier product-limit method |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heinz-Josef Lenz | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033-0804 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Observed Response Rate. | 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. | 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. | Number | 95% Confidence Interval | Percentage of Participants | Best response recorded from the start of treatment until disease progression/recurrence. Assessed every 2 cycles. |
1 year, 5 months
All adverse events (all grades & attributions) that were not identified as serious are included in "Other" events table.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
Of 12 pts accrued\treated, none responded. The initial phase accrual goal was 15, but given the 12 non-responders, we determined the probability of 3 future pts all responding (stochastic curtailed sampling) at 2.7%. Decided to terminate the trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DCC Project Administrator | California Cancer Consortium | 626-256-4673 | 60094 | CCCP@coh.org |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C046785 | bryostatin 1 |
| D054713 | Bryostatins |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D000095702 | Polyether Toxins |
| D000095662 | Polyether Polyketides |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
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| cisplatin | Drug | Given IV |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| 18 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | 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 |
|
|
| Secondary | Overall Survival | Overall survival was estimated according to the Kaplan-Meier product-limit method. | Median | 95% Confidence Interval | Months | 18 months |
|
|
|
| Secondary | Progression-free Survival | Progression-free survival was estimated according to the Kaplan-Meier product-limit method | Median | 95% Confidence Interval | months | 18 months |
|
|
|
| 5 |
| 12 |
| 12 |
| 12 |
| Transfusion: pRBCs | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
|
| Supraventricular and nodal arrhythmia | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | meddra9.0 | Non-systematic Assessment |
|
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | meddra9.0 | Non-systematic Assessment |
|
| Bilirubin (hyperbilirubinemia) | Investigations | meddra9.0 | Non-systematic Assessment |
|
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
|
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
|
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | meddra9.0 | Non-systematic Assessment |
|
| Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
|
| Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
|
| Transfusion: pRBCs | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
|
| Supraventricular and nodal arrhythmia | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
|
| Diarrhea patients with a colostomy | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
|
| Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation) | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
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| Mucositis/stomatitis (functional/symptomatic) | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
|
| Constitutional Symptoms - Other (Specify, __) | General disorders | meddra9.0 | Non-systematic Assessment |
|
| Edema | General disorders | meddra9.0 | Non-systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | meddra9.0 | Non-systematic Assessment |
|
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | meddra9.0 | Non-systematic Assessment |
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| Rigors/chills | General disorders | meddra9.0 | Non-systematic Assessment |
|
| Infection - Other (Specify, __) | Infections and infestations | meddra9.0 | Non-systematic Assessment |
|
| Infection without neutropenia | Infections and infestations | meddra9.0 | Non-systematic Assessment |
|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | meddra9.0 | Non-systematic Assessment |
|
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | meddra9.0 | Non-systematic Assessment |
|
| Alkaline phosphatase | Investigations | meddra9.0 | Non-systematic Assessment |
|
| Bilirubin (hyperbilirubinemia) | Investigations | meddra9.0 | Non-systematic Assessment |
|
| Cholesterol, serum-high (hypercholesteremia) | Investigations | meddra9.0 | Non-systematic Assessment |
|
| Creatinine | Investigations | meddra9.0 | Non-systematic Assessment |
|
| FEV(1) | Investigations | meddra9.0 | Non-systematic Assessment |
|
| INR (International Normalized Ratio of prothrombin time) | Investigations | meddra9.0 | Non-systematic Assessment |
|
| Leukocytes (total WBC) | Investigations | meddra9.0 | Non-systematic Assessment |
|
| Lymphopenia | Investigations | meddra9.0 | Non-systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) for leukemia studies or bm infiltrative/myelophthisic | Investigations | meddra9.0 | Non-systematic Assessment |
|
| Platelets | Investigations | meddra9.0 | Non-systematic Assessment |
|
| Weight loss | Investigations | meddra9.0 | Non-systematic Assessment |
|
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
|
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
|
| Magnesium, serum-high (hypermagnesemia) | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
|
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
|
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
|
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
|
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
|
| Sodium, serum-high (hypernatremia) | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
|
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
|
| Neuropathy: motor | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
|
| Neuropathy: sensory | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
|
| Pain | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
|
| Confusion | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
|
| Mood alteration | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
|
| Obstruction, GU | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
|
| Urinary frequency/urgency | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
|
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
|
| Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
|
| Pruritus/itching | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | meddra9.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | meddra9.0 | Non-systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D009930 |
| Organic Chemicals |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D008387 | Marine Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |