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Erlotinib Plus Carboplatin and Paclitaxel in Ovarian Carcinoma

Primary Purpose

Brenner Tumor, Fallopian Tube Cancer, Ovarian Clear Cell Cystadenocarcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
paclitaxel
carboplatin
erlotinib
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brenner Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Patients with a histologic diagnosis of primary peritoneal carcinoma, fallopian tube epithelial ovarian carcinoma, Stage III with either greater than 1 cm (suboptimal) residual disease following initial surgery, or Stage IV; all patients must either have had appropriate surgery for ovarian, fallopian tube or peritoneal carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage or must be unresectable at time of diagnosis (to be determined by gynecological oncologist); cytology alone is not adequate Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (NOS) Patients must begin chemotherapy on this study no more than twelve weeks postoperatively Patients must not have received chemotherapy within five years prior to enrollment ECOG performance status =< 2 (Karnofsky >= 60%) Absolute neutrophil count >= 1,500/uL Platelets >= 100,000/uL Total bilirubin =< 1.5 x institutional upper limit of normal AST(SGOT)/ALT(SGPT) =< 2.5 x institutional upper limit of normal Creatinine =< 1.5 x institutional upper limit of normal OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal Neuropathy (sensory and motor) =< CTC grade 1 No medical contraindications to planned regimen Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Patients who have had courses of chemotherapy within the five years prior to entering the study Patients may not be receiving any other investigational agents Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events History of allergic reactions attributed to compounds of similar chemical or biologic composition OSI-774 or other agents used in the study Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded from this study because OSI-774 has the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with OSI-774, breastfeeding should be discontinued if the mother is treated with OSI-774; these potential risks may also apply to other agents used in this study Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with OSI-774 or other agents administered during the study; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel, carboplatin, erlotinib

Arm Description

Carboplatin and paclitaxel IV every 21 days x 6 cycles plus oral erlotinib

Outcomes

Primary Outcome Measures

Pathologic Complete Response Rates
Pathologic complete response was defined as having no pathologic or cytologic evidence of disease following surgical reassessment.
The Percentage of Participants Experiencing Toxicty (Grade 2 and Grade 3/4) Associated With the Combined Regimen
Adverse event assessment

Secondary Outcome Measures

To Measure EGFR Gene Amplification in Tumor Specimens
To Determine Progession Free Survival With the Addition of OSI-774 (Tarceva) to the Combination of Paclitaxel and Carboplatin
To Determine the Tolerability of Twelve Months of Maintenance Treatment

Full Information

First Posted
May 6, 2003
Last Updated
October 29, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00059787
Brief Title
Erlotinib Plus Carboplatin and Paclitaxel in Ovarian Carcinoma
Official Title
Phase II Study of Erlotinib Plus Carboplatin and Paclitaxel in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brenner Tumor, Fallopian Tube Cancer, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mucinous Cystadenocarcinoma, Ovarian Serous Cystadenocarcinoma, Ovarian Undifferentiated Adenocarcinoma, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel, carboplatin, erlotinib
Arm Type
Experimental
Arm Description
Carboplatin and paclitaxel IV every 21 days x 6 cycles plus oral erlotinib
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
Anzatax, Asotax, TAX, Taxol
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
erlotinib
Other Intervention Name(s)
CP-358,774, OSI-774
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Pathologic Complete Response Rates
Description
Pathologic complete response was defined as having no pathologic or cytologic evidence of disease following surgical reassessment.
Time Frame
Up to 7 years
Title
The Percentage of Participants Experiencing Toxicty (Grade 2 and Grade 3/4) Associated With the Combined Regimen
Description
Adverse event assessment
Time Frame
For the duration of the study up to 7 years
Secondary Outcome Measure Information:
Title
To Measure EGFR Gene Amplification in Tumor Specimens
Time Frame
The duration of the study for up to 7 years
Title
To Determine Progession Free Survival With the Addition of OSI-774 (Tarceva) to the Combination of Paclitaxel and Carboplatin
Time Frame
The duration of the study
Title
To Determine the Tolerability of Twelve Months of Maintenance Treatment
Time Frame
Twelve months of maintenance

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a histologic diagnosis of primary peritoneal carcinoma, fallopian tube epithelial ovarian carcinoma, Stage III with either greater than 1 cm (suboptimal) residual disease following initial surgery, or Stage IV; all patients must either have had appropriate surgery for ovarian, fallopian tube or peritoneal carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage or must be unresectable at time of diagnosis (to be determined by gynecological oncologist); cytology alone is not adequate Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (NOS) Patients must begin chemotherapy on this study no more than twelve weeks postoperatively Patients must not have received chemotherapy within five years prior to enrollment ECOG performance status =< 2 (Karnofsky >= 60%) Absolute neutrophil count >= 1,500/uL Platelets >= 100,000/uL Total bilirubin =< 1.5 x institutional upper limit of normal AST(SGOT)/ALT(SGPT) =< 2.5 x institutional upper limit of normal Creatinine =< 1.5 x institutional upper limit of normal OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal Neuropathy (sensory and motor) =< CTC grade 1 No medical contraindications to planned regimen Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Patients who have had courses of chemotherapy within the five years prior to entering the study Patients may not be receiving any other investigational agents Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events History of allergic reactions attributed to compounds of similar chemical or biologic composition OSI-774 or other agents used in the study Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded from this study because OSI-774 has the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with OSI-774, breastfeeding should be discontinued if the mother is treated with OSI-774; these potential risks may also apply to other agents used in this study Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with OSI-774 or other agents administered during the study; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Blank
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467-2490
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20837357
Citation
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.
Results Reference
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Erlotinib Plus Carboplatin and Paclitaxel in Ovarian Carcinoma

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