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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03593 | Registry Identifier | Clinical Trials Reporting Program |
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Due to lack of funding provided for Phase II portion of trial
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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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This study will determine the maximum tolerated dose of the triplet combination of capecitabine that can be administered in combination with weekly paclitaxel and every four weeks with carboplatin.
Rationale: The combination of the chemotherapy drugs paclitaxel and carboplatin is one of the most common combination regimens used in clinical practice for cancer. These agents are used for a variety of cancers. The current study builds on previous research about treatment schedules for administering these agents to reduce toxicity and optimize efficacy. The phase I and II portions of the current study combine paclitaxel and carboplatin with capecitabine in patients. Researchers are seeking to identify the highest dose of capecitabine and paclitaxel in combination with carboplatin for this patient population, as well as to gather information about preliminary efficacy.
Purpose: The phase I portion of this study will evaluate the maximum tolerated dose of capecitabine and paclitaxel in combination with carboplatin for patients. The phase II portion of this study will assess the objective response rate in patients using the same treatment combination. Toxicities will be closely measured in both phases of the study.
Treatment: Patients in this study will be given capecitabine, carboplatin, and paclitaxel. Capecitabine will be given through oral pills. Carboplatin and paclitaxel will be given through intravenous infusions. Treatment drugs will be given on a four-week cycle. Carboplatin will be administered on day 1, paclitaxel weekly for the first 3 weeks, and capecitabine twice daily on days 8 through 21 of each cycle. No treatments will be given during the fourth week of each treatment cycle. During the phase I portion of the study, patients may receive different doses of capecitabine and paclitaxel since the purpose is to identify the maximum tolerated dose of each drug in combination with carboplatin. Once the maximum tolerated dose of these agents is identified during phase I, the phase II portion of the study will begin. Treatments will be discontinued due to disease growth or unacceptable side effects. Several tests and exams will be given throughout the study to closely monitor patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive paclitaxel IV over 60 minutes on days 1, 8, and 15, carboplatin IV over 1-2 hours on day 1, and capecitabine PO BID on days 8-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | Level 1: 500 mg/m2 orally twice daily Days 8 - 21 of each cycle. Level 2: 750 mg/m2 orally twice daily Days 8 - 21 of each cycle. Level 3 - 5: 1000mg/m2 orally twice daily Days 8 - 21 of each cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose in Phase I Portion of Study | Determine the maximum tolerated dose of the triplet combination of capecitabine that can be administered in combination with weekly paclitaxel and every four weeks carboplatin. | Every 3 weeks, for up to 24 weeks |
| Objective Response Rate (ORR) for the Phase II Portion of the Study. CR+PR Per RECIST v1.0 Criteria Using a Single Arm , Two Stage Minimax Design. | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR | Every 3 weeks, for up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: To Determine Side Effects | The common clinically significant grade 3 and 4 toxicities graded using the National Cancer Institutes Common Toxicity Criteria version 3.0 | Every 3 weeks, for up to 24 weeks |
| Progression-Free Survival at 6 Months for Patients |
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Inclusion Criteria for Phase I:
Inclusion Criteria for Phase II:
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| Name | Affiliation | Role |
|---|---|---|
| Tony Bekaii-Saab | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26416564 | Background | Mikhail S, Lustberg MB, Ruppert AS, Mortazavi A, Monk P, Kleiber B, Villalona-Calero M, Bekaii-Saab T. Biomodulation of capecitabine by paclitaxel and carboplatin in advanced solid tumors and adenocarcinoma of unknown primary. Cancer Chemother Pharmacol. 2015 Nov;76(5):1005-12. doi: 10.1007/s00280-015-2877-6. Epub 2015 Sep 28. |
| Label | URL |
|---|---|
| Jamesline | View source |
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Patients were enrolled to the trial between July 2005 and November 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I | Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest. |
| FG001 | Phase II |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Carboplatin | Drug | Levels 1-5: AUC of 6 every 4 weeks. |
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| Paclitaxel | Drug | Level 1-3: 60 mg/m2/week. Level 4: 80 mg/m2/week. Level 5: 100 mg/m2/week. |
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For patients enrolled on the Phase II portion of the trial Progression Free Survival (PFS) was measured from the percentage of patients that were still alive, without evidence of disease progression for 6 months following the initiation of treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| up to 6 years |
| One Year Survival for Patients | For patients enrolled on the Phase II portion of the trial the One-year survival was measured as the percentage of patients alive 1 year after their treatment in the trial. | Up to 1 year |
| Time to Tumor Progression for Patients | For patients enrolled on the Phase II portion of the trial the time to progression was measured as the time from when the patient started treatment to the time the patient is first recorded as having disease progression or the date of death if the patient dies due to causes other than disease progression. | Up to 6 years |
Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site. |
| Patients Not Evaluable |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I | Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest. |
| BG001 | Phase II | Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | patients |
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| 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 | Maximum Tolerated Dose in Phase I Portion of Study | Determine the maximum tolerated dose of the triplet combination of capecitabine that can be administered in combination with weekly paclitaxel and every four weeks carboplatin. | Posted | Number | mg/m2 | Every 3 weeks, for up to 24 weeks |
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| Primary | Objective Response Rate (ORR) for the Phase II Portion of the Study. CR+PR Per RECIST v1.0 Criteria Using a Single Arm , Two Stage Minimax Design. | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR | The Phase II study was prematurely terminated at 25 patients due to cessation of funding | Posted | Number | 95% Confidence Interval | percent of patients | Every 3 weeks, for up to 24 weeks |
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| Secondary | Phase I: To Determine Side Effects | The common clinically significant grade 3 and 4 toxicities graded using the National Cancer Institutes Common Toxicity Criteria version 3.0 | Three patients enrolled on Phase I portion of trial were not evaluable for toxicity. | Posted | Number | percent of patients | Every 3 weeks, for up to 24 weeks |
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| Secondary | Progression-Free Survival at 6 Months for Patients | For patients enrolled on the Phase II portion of the trial Progression Free Survival (PFS) was measured from the percentage of patients that were still alive, without evidence of disease progression for 6 months following the initiation of treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | Posted | Number | 95% Confidence Interval | percent of patients | up to 6 years |
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| Secondary | One Year Survival for Patients | For patients enrolled on the Phase II portion of the trial the One-year survival was measured as the percentage of patients alive 1 year after their treatment in the trial. | Posted | Number | 95% Confidence Interval | percent of patients | Up to 1 year |
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| Secondary | Time to Tumor Progression for Patients | For patients enrolled on the Phase II portion of the trial the time to progression was measured as the time from when the patient started treatment to the time the patient is first recorded as having disease progression or the date of death if the patient dies due to causes other than disease progression. | Posted | Median | 95% Confidence Interval | months | Up to 6 years |
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Adverse Events were graded using the National Cancer Institute Common Toxicity Criteria version 3.0.
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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 | Phase I | Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest. | 0 | 29 | 29 | 29 | ||
| EG001 | Phase II | Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site. | 0 | 25 | 25 | 25 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
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| Anorexia | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE version 3.0 | Systematic Assessment |
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| Fever without Neutropenia | General disorders | CTCAE version 3.0 | Systematic Assessment |
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| Hand Foot Syndrome | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Systematic Assessment |
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| Mucositis | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
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| Neuropathy | Nervous system disorders | CTCAE version 3.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tanios Bekaii-Saab, MD | The Ohio State University Comprehensive Cancer Center | 614-293-9863 | tanios.bekaii-saab@osumc.edu |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009382 | Neoplasms, Unknown Primary |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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