Trial of Pemetrexed and Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer
NCT ID: NCT00489359
Last Updated: 2011-06-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
86 participants
INTERVENTIONAL
2005-07-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pemetrexed/Carboplatin Phase 1
Pemetrexed was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.
Carboplatin was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
Pemetrexed - Phase 1
500, 600, 700, 800, or 900 milligrams per square meter (mg/m\^2), administered intravenously (IV), every 21 days x 6 cycles, dose escalate to Maximum Tolerated Dose (MTD)
Carboplatin - Phase 1
area under the concentration time curve (AUC) 5 or 6 mg/mL\*min, administered intravenously (IV), every 21 days x 6 cycles, dose escalation to Maximum Tolerated Dose (MTD)
Pemetrexed/Carboplatin Phase 2
Pemetrexed was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.
Carboplatin was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
Pemetrexed - Phase 2
Dose determined from Phase 1: 500 mg/m\^2, administered IV, every 21 days x 6 cycles
Carboplatin - Phase 2
Dose determined from Phase 1: AUC 6 mg/mL\*min, administered IV, every 21 days x 6 cycles
Interventions
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Pemetrexed - Phase 1
500, 600, 700, 800, or 900 milligrams per square meter (mg/m\^2), administered intravenously (IV), every 21 days x 6 cycles, dose escalate to Maximum Tolerated Dose (MTD)
Carboplatin - Phase 1
area under the concentration time curve (AUC) 5 or 6 mg/mL\*min, administered intravenously (IV), every 21 days x 6 cycles, dose escalation to Maximum Tolerated Dose (MTD)
Pemetrexed - Phase 2
Dose determined from Phase 1: 500 mg/m\^2, administered IV, every 21 days x 6 cycles
Carboplatin - Phase 2
Dose determined from Phase 1: AUC 6 mg/mL\*min, administered IV, every 21 days x 6 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have recurrent ovarian cancer which is sensitive to platinum therapy
* Prior radiation therapy is allowed
Measurable disease as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines, or non-measurable but cancer antigen 125 (CA-125) greater than or equal to 2X upper limit.
Exclusion Criteria
* Pregnant or breast feeding.
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
18 Years
FEMALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Eli Lilly
Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bahía Blanca, , Argentina
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Buenos Aires, , Argentina
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Ramos Mejía, , Argentina
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Salta, , Argentina
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Calgary, Alberta, Canada
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Toronto, Ontario, Canada
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Berlin, , Germany
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Bonn, , Germany
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Chemnitz, , Germany
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Düsseldorf, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Hamburg, , Germany
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Jena, , Germany
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Kiel, , Germany
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Mainz, , Germany
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Tübingen, , Germany
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Gdansk, , Poland
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Olsztyn, , Poland
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Warsaw, , Poland
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Gothenburg, , Sweden
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Lund, , Sweden
Countries
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References
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Bookman MA. 2006. GOG0182-ICON5: 5-arm phase III randomized trial of paclitaxel (P) and carboplatin (C) vs combinations with gemcitabine (G), PEG-lipososomal doxorubicin (D), or topotecan (T) in patients (pts) with advanced-stage epithelial ovarian (EOC) or primary peritoneal (PPC) carcinoma. J Clin Oncol 24 (suppl 18S). Abstract 5002.
Sehouli J, Alvarez AM, Manouchehrpour S, Ghatage P, Szczylik C, Zimmermann A, Bauknecht T, Look KY, Oskay-Oezcelik G. A phase II trial of pemetrexed in combination with carboplatin in patients with recurrent ovarian or primary peritoneal cancer. Gynecol Oncol. 2012 Feb;124(2):205-9. doi: 10.1016/j.ygyno.2011.09.007. Epub 2011 Nov 1.
Other Identifiers
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H3E-MC-JMHH
Identifier Type: OTHER
Identifier Source: secondary_id
9516
Identifier Type: -
Identifier Source: org_study_id
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