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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| Pharmacia and Upjohn | INDUSTRY |
| Eli Lilly and Company | INDUSTRY |
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In this randomized trial, we will investigate the activity and toxicity of two active regimens, gemcitabine/irinotecan and paclitaxel/carboplatin/Etoposide (both followed by ZD1839) in the first-line treatment of patients with carcinoma of unknown primary site.
Upon determination of eligibility, all patients will be randomly assigned to one of two treatment arms:
Patients will be stratified by tumor location (liver/bone versus all others) and number of metastatic sites (one versus two or more). Patients with an objective response or stable disease after completion of chemotherapy will receive ZD1839 until disease progression. Patients who do not respond to chemotherapy may crossover to the other chemotherapy regimen and will receive ZD1839 if they have an objective response or stable disease. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A | Experimental | Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1 Carboplatin area under the curve (AUC) 6.0 IV, day 1 Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10 Regimen A was repeated at a 21-day interval |
|
| Regimen B | Experimental | Irinotecan 100 mg/m2 IV, days 1 and 8 Gemcitabine 1000 mg/m2 IV, days 1 and 8 Regimen B was repeated at a 21-day interval |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etoposide | Drug | 50 mg alternating with 100 mg PO, days 1 and 10 in regimen A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death | Length of time, in months, that patients were alive from their first date of protocol treatment until death. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease | Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease | 12 months |
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Inclusion Criteria:
To be included in this study, you must meet the following criteria:
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
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| Name | Affiliation | Role |
|---|---|---|
| John D. Hainsworth, MD | SCRI Development Innovations, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeast Alabama Regional Medical Center | Anniston | Alabama | 36207 | United States | ||
| Clearview Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20164695 | Result | Hainsworth JD, Spigel DR, Clark BL, Shipley D, Thompson DS, Farley C, West-Osterfield K, Lane CM, Cescon T, Bury MJ, Greco FA. Paclitaxel/carboplatin/etoposide versus gemcitabine/irinotecan in the first-line treatment of patients with carcinoma of unknown primary site: a randomized, phase III Sarah Cannon Oncology Research Consortium Trial. Cancer J. 2010 Jan-Feb;16(1):70-5. doi: 10.1097/PPO.0b013e3181c6aa89. |
| Label | URL |
|---|---|
| Published article in The Cancer Journal | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paclitaxel/Carboplatin/Etoposide/Gefitinib | Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1 Carboplatin area under the curve (AUC) 6.0 IV, day 1 Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10 Regimen A was repeated at a 21-day interval |
| FG001 | Irinotecan/Gemcitabine/Gefitinib |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Gemcitabine | Drug | 1000 mg/m2 IV, days 1 and 8, in regimen B |
|
|
| Irinotecan | Drug | 1000 mg/m2 IV days 1 and 8 in regimen B |
|
|
| Paclitaxel | Drug | 200 mg/m2 by 1-hour IV infusion, day 1, regimen A |
|
|
| Carboplatin | Drug | Area under the curve (AUC) 6.0 IV, day 1, regimen A |
|
|
| Huntsville |
| Alabama |
| 35805 |
| United States |
| Southern Cancer Center, Sacred Heart Heath System Medical Oncology Group | Mobile | Alabama | 36608 | United States |
| Northeast Arkansas Clinic | Jonesboro | Arkansas | 72401 | United States |
| Tower Oncology | Beverly Hills | California | 90211 | United States |
| Watson Clinic Center for Cancer Care and Research | Lakeland | Florida | 33805 | United States |
| Mercy Hospital Miami | Miami | Florida | 33133 | United States |
| Florida Hospital Cancer Institute | Orlando | Florida | 32804 | United States |
| Phoebe Cancer Center | Albany | Georgia | 31701 | United States |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States |
| Wellstar Cancer Research | Marietta | Georgia | 30060 | United States |
| Oncology Hematology Associates of SW Indiana | Evansville | Indiana | 47714 | United States |
| Graves-Gilbert Clinic | Bowling Green | Kentucky | 42101 | United States |
| Consultants in Blood Disorders and Cancer | Louisville | Kentucky | 40207 | United States |
| Terrebonne General Medical Center | Houma | Louisiana | 70360 | United States |
| Mercy Hospital | Portland | Maine | 04101 | United States |
| Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan | 49503 | United States |
| St. Joseph Mercy Oakland Hospital, Cancer Center | Pontiac | Michigan | 48341 | United States |
| Jackson Oncology Associates | Jackson | Mississippi | 39202 | United States |
| Montana Cancer Institute Foundation | Missoula | Montana | 59802 | United States |
| Methodist Cancer Center | Omaha | Nebraska | 68114 | United States |
| Aultman Hospital | Canton | Ohio | 44710 | United States |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | United States |
| Consultants in Medical Oncology and Hematology | Drexel Hill | Pennsylvania | 19026 | United States |
| Reading Hospital Regional Cancer Center | West Reading | Pennsylvania | 19612 | United States |
| Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Kingsport Hematology-Oncology | Kingsport | Tennessee | 37660 | United States |
| Thompson Cancer Survival Center | Knoxville | Tennessee | 37916 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37023 | United States |
| South Texas Oncology and Hematology | San Antonio | Texas | 78258 | United States |
| Cancer Outreach Associates | Abingdon | Virginia | 24211 | United States |
Irinotecan 100 mg/m2 IV, days 1 and 8 Gemcitabine 1000 mg/m2 IV, days 1 and 8 Regimen B was repeated at a 21-day interval |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Paclitaxel/Carboplatin/Etoposide/Gefitinib | Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1 Carboplatin area under the curve (AUC) 6.0 IV, day 1 Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10 Regimen A was repeated at a 21-day interval |
| BG001 | Irinotecan/Gemcitabine/Gefitinib | Irinotecan 100 mg/m2 IV, days 1 and 8 Gemcitabine 1000 mg/m2 IV, days 1 and 8 Regimen B was repeated at a 21-day interval |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death | Length of time, in months, that patients were alive from their first date of protocol treatment until death. | Posted | Median | 95% Confidence Interval | months | 24 months |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease | Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease | Posted | Median | 95% Confidence Interval | months | 12 months |
|
|
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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 | Paclitaxel/Carboplatin/Etoposide/Gefitinib | Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1 Carboplatin area under the curve (AUC) 6.0 IV, day 1 Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10 Regimen A was repeated at a 21-day interval | 56 | 93 | 93 | 93 | ||
| EG001 | Irinotecan/Gemcitabine/Gefitinib | Irinotecan 100 mg/m2 IV, days 1 and 8 Gemcitabine 1000 mg/m2 IV, days 1 and 8 Regimen B was repeated at a 21-day interval | 57 | 105 | 105 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular - Other | Eye disorders | CTCAE (3.0) | Systematic Assessment | Temporary unilateral blindness |
|
| Febrile Neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Death | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - Skin | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Superventricular Arrhythmia - Supraventricular tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Abdomen | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with Unknown ANC | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/Thrombus/Embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - GI | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiopulmonary Arrest | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pancreatitis | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neurology - Other | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Cauda Equina Syndrome |
|
| Pulmonary - COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| ARDS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Confusion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic Reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary - Bronchitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Obstruction - Bile Duct | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Respiratary - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Interstitial lung changes |
|
| Ulcer, GI | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - Renal/Genitourinary | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Fracture | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Obstruction - GI | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - Sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| GI - Other | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Ischemic Bowel |
|
| Edema: Head and Neck | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Reflux | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Valvular Heart Disease | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hiccoughs | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Peripheal Arterial Ischemia | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vasovagal Episode | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Liver Dysfunction | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema - NOS | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile Neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/Stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary - NOS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Hainsworth, MD | Sarah Cannon Research Institute | 1-877-691-7274 | asksarah@scresearch.net |
| ID | Term |
|---|---|
| D009382 | Neoplasms, Unknown Primary |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005047 | Etoposide |
| C061400 | etoposide phosphate |
| D000093542 | Gemcitabine |
| D000077146 | Irinotecan |
| D017239 | Paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D056831 | Coordination Complexes |
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| Male |
|
|