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| ID | Type | Description | Link |
|---|---|---|---|
| NYU 02-30 | Other Identifier | New York University | |
| N01CM62204 | U.S. NIH Grant/Contract | View source |
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This phase II trial is studying the side effects of giving erlotinib together with carboplatin and paclitaxel and to see how well it works in treating patients with stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy such as carboplatin and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die.
PRIMARY OBJECTIVES:
I. To establish whether the addition of OSI-774 (Tarceva) to the combination of paclitaxel and carboplatin encourages pathologic complete response (pCR) rates in patients with Stage III optimally cytoreduced (stratum 1) and Stage III suboptimally cytoreduced or Stage IV (stratum 2) ovarian, primary peritoneal or fallopian tube carcinomas when used as front line therapy.
II. To determine the degree and type of toxicity associated with this combined regimen.
SECONDARY OBJECTIVES:
I. To establish baseline epidermal growth factor receptor (EGFR), truncated EGFR (EGFRvIII), phosphorylated EGFR (pEGFR) and related signal transduction pathway protein expression levels (such as the mitogen activated protein kinase p-ERK, AKT phosphorylation and Her2/neu) in tumor samples obtained pretreatment, and to correlate these with achieving pCR.
II. To describe changes in EGFR, EGFRvIII, pEGFR expression levels and other related signal transduction pathway expression occurring during treatment with OSI-774 in combination with chemotherapy.
III. To determine the effect of the addition of OSI-774 (Tarceva) to the combination of paclitaxel and carboplatin on progression-free interval in patients with Stage III optimally cytoreduced (stratum 1) and Stage III suboptimally cytoreduced or Stage IV (stratum 2) ovarian or primary peritoneal carcinomas when used as front line therapy.
IV. To determine the tolerability of twelve months of maintenance treatment with OSI-774 for patients achieving pCR, and to measure the progression-free interval for this population.
V. To document cutaneous effects of OSI 774 prospectively, and to correlate the degree of skin rash with clinical and translational endpoints.
OUTLINE: This is a non-randomized study. Patients are stratified according to disease stage (stage III with optimal residual disease vs stage III with suboptimal residual disease or stage IV).
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel, carboplatin, erlotinib | Experimental | Carboplatin and paclitaxel IV every 21 days x 6 cycles plus oral erlotinib |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel | Drug | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response Rates | Pathologic complete response was defined as having no pathologic or cytologic evidence of disease following surgical reassessment. | Up to 7 years |
| The Percentage of Participants Experiencing Toxicty (Grade 2 and Grade 3/4) Associated With the Combined Regimen | Adverse event assessment | For the duration of the study up to 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| To Measure EGFR Gene Amplification in Tumor Specimens | The duration of the study for up to 7 years | |
| To Determine Progession Free Survival With the Addition of OSI-774 (Tarceva) to the Combination of Paclitaxel and Carboplatin | The duration of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Blank | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467-2490 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20837357 | Result | Blank SV, Christos P, Curtin JP, Goldman N, Runowicz CD, Sparano JA, Liebes L, Chen HX, Muggia FM. Erlotinib added to carboplatin and paclitaxel as first-line treatment of ovarian cancer: a phase II study based on surgical reassessment. Gynecol Oncol. 2010 Dec;119(3):451-6. doi: 10.1016/j.ygyno.2010.08.008. Epub 2010 Sep 15. |
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A total of 56 patients were enrolled between June 2003 and December 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride) | Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months. paclitaxel: Given IV carboplatin: Given IV erlotinib hydrochloride: Given PO laboratory biomarker analysis: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| carboplatin | Drug | Given IV |
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| erlotinib | Drug | Given PO |
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| To Determine the Tolerability of Twelve Months of Maintenance Treatment | Twelve months of maintenance |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride) | Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months. paclitaxel: Given IV carboplatin: Given IV erlotinib hydrochloride: Given PO laboratory biomarker analysis: Correlative studies |
| 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, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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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 | Pathologic Complete Response Rates | Pathologic complete response was defined as having no pathologic or cytologic evidence of disease following surgical reassessment. | Patients who had optimally debulking surgery | Posted | Number | participants | Up to 7 years |
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| Primary | The Percentage of Participants Experiencing Toxicty (Grade 2 and Grade 3/4) Associated With the Combined Regimen | Adverse event assessment | Patients enrolled on all stratums included | Posted | Number | percentage of participants | For the duration of the study up to 7 years |
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| Secondary | To Measure EGFR Gene Amplification in Tumor Specimens | Tumor specimens were evaluated for EGFR gene amplification in 20 patients | Posted | Number | number of tumor specimens | The duration of the study for up to 7 years |
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| Secondary | To Determine Progession Free Survival With the Addition of OSI-774 (Tarceva) to the Combination of Paclitaxel and Carboplatin | Posted | Median | 95% Confidence Interval | months | The duration of the study |
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| Secondary | To Determine the Tolerability of Twelve Months of Maintenance Treatment | Posted | Number | participants | Twelve months of maintenance |
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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 (Paclitaxel, Carboplatin, Erlotinib Hydrochloride) | Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months. paclitaxel: Given IV carboplatin: Given IV erlotinib hydrochloride: Given PO laboratory biomarker analysis: Correlative studies | 20 | 56 | 17 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Rash: desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Alanine transaminase | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
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| Aspartate transaminase | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Nausea | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Rash: desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Mucositis: oral | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain: abdomen | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| NYCC Regulatory Coordinator | Montefiore Medical Center - New York Cancer Consortium | 718-379-6862 | sforde@montefiore.org |
| ID | Term |
|---|---|
| D001948 | Brenner Tumor |
| D005185 | Fallopian Tube Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D018225 | Neoplasms, Fibroepithelial |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D010051 | Ovarian Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D009371 | Neoplasms by Site |
| D005184 | Fallopian Tube Diseases |
| D002277 | Carcinoma |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D013660 | Taxes |
| D016190 | Carboplatin |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D056831 | Coordination Complexes |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| White |
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| Other |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Grade 3-4 neutropenia |
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| Grade 3-4 skin rash |
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| Grade 3-4 thrombocytopenia |
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| Grade 3-4 infection |
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| Grade 3-4 fatigue |
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| Grade 3 diarrhea |
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| Grade 2 skin rash |
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| Grade 2 diarrhea |
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| Title | Denominators | Categories |
|---|
| No amplification |
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| Low-level amplification |
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| moderate high amplification |
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