Erlotinib Plus Carboplatin and Paclitaxel in Ovarian Carcinoma
Phase II Study of Erlotinib Plus Carboplatin and Paclitaxel in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
3 other identifiers
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2003
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 6, 2003
CompletedFirst Posted
Study publicly available on registry
May 7, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
December 1, 2015
CompletedDecember 1, 2015
May 1, 2013
7.1 years
May 6, 2003
April 29, 2015
October 29, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (3)
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
To Determine the Tolerability of Twelve Months of Maintenance Treatment
Twelve months of maintenance
Study Arms (1)
Paclitaxel, carboplatin, erlotinib
EXPERIMENTALCarboplatin and paclitaxel IV every 21 days x 6 cycles plus oral erlotinib
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montefiore Medical Center
The Bronx, New York, 10467-2490, United States
Related Publications (1)
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.
PMID: 20837357RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- NYCC Regulatory Coordinator
- Organization
- Montefiore Medical Center - New York Cancer Consortium
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie Blank
Montefiore Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2003
First Posted
May 7, 2003
Study Start
April 1, 2003
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
December 1, 2015
Results First Posted
December 1, 2015
Record last verified: 2013-05