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Trial of Pemetrexed and Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer

Primary Purpose

Ovarian Cancer, Primary Peritoneal Cancer

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Pemetrexed - Phase 1

Carboplatin - Phase 1

Pemetrexed - Phase 2

Carboplatin - Phase 2

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

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

Inclusion Criteria:

Diagnosis of ovarian or primary peritoneal cancer confirmed by pathology
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:

More than 2 lines of therapy for ovarian or primary peritoneal cancer.
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.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Pemetrexed/Carboplatin Phase 1

Pemetrexed/Carboplatin Phase 2

Arm Description

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.

Outcomes

Primary Outcome Measures

Phase 1 - Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Carboplatin

MTD was to be determined by increasing doses of pemetrexed up to 900 mg/m^2 and carboplatin Area Under the Concentration-Time Curve (AUC) up to 6 mg/mL*min based on observed pattern of dose limiting toxicity (DLT). See Outcome #3 for DLT. If none of 3 initial participants at a given level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level. If at least 2 participants experienced a DLT in Cycle 1 at a dose level, that dose level was considered the MTD. However, based on results from a different Phase 2 Study (NCT00109096), further dose escalations were not explored.

Phase 2 - Percentage of Participants With Overall Tumor Response (Response Rate)

Response is defined as CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. Response rate (%) = (number of patients with CR+PR/number of patients in Phase 2)*100

Secondary Outcome Measures

Phase 1 - Number of Dose-Limiting Toxicities (DLTs)

The following toxicities were considered DLT: CTCAE Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5 × 10^9/L lasting ≥7 days. Febrile neutropenia (ANC <1.0 × 10^9/L, fever 38.5°C, and no documented infection). CTCAE Grade 4 thrombocytopenia (platelets <25.0 × 10^9/L). Any hemorrhage with CTCAE Grade ≥3 thrombocytopenia (50.0 × 10^9/L). CTCAE Grade ≥3 nonhematologic toxicity (excluding nausea, vomiting, or CTCAE Grade 3 alanine transaminase (ALT) or aspartate aminotransferase (AST) that returned to baseline prior to next treatment). Treatment delay more than 1 week due to toxicity.

Phase 1 - Number of Participants With Adverse Events (Toxicity)

A listing of adverse events is located in the Reported Adverse Event module.

Phase 1 - Recommended Dose of Pemetrexed for Phase 2

MTD was to be used as Phase 2 recommended dose. MTD was to be determined by increasing doses of pemetrexed up to 900 mg/m^2 based on observed pattern of dose limiting toxicity (DLT: See Outcome #3). If none of 3 initial participants at a given level had a DLT in Cycle 1, enrollment proceeded to next dose level. If at least 2 participants had a DLT in Cycle 1 at a dose level, that dose level was considered the MTD. However, based on results from another Phase 2 Study (NCT00109096), further dose escalations were not explored and dose was selected based on results of that Phase 2 Study.

Phase 1 - Recommended Area Under the Curve (AUC) Dose of Carboplatin for Phase 2

MTD was to be used as Phase 2 recommended dose. MTD determined by increasing doses up to AUC 6 mg/mL*min based on pattern of DLT (Outcome #3). If none of 3 initial participants at given level had DLT in Cycle 1, enrollment proceeded to next dose level. If at least 2 participants had DLT in Cycle 1 at dose level, that dose level was considered MTD. However, based on results from Phase 2 Study (NCT00109096), further dose escalations were not explored: carboplatin dose was selected based on standard dose employed in control arm of first-line therapy for epithelial ovarian cancer (Bookman 2006).

Phase 1 - Number of Participants With Tumor Response

Patients were analyzed by Cancer Antigen-125 (CA-125) response criteria and RECIST guidelines. Possible evaluations include: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Phase 2 - Time to Response (TTR)

Response is defined as CR (Complete Response) or PR (Partial Response) per RECIST criteria. Possible evaluations include: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Phase 2 - Duration of Response (DOR)

Duration of response is defined as the time from first observation of Complete Response or Partial Response to the first observation of Progressive Disease or death from any cause. For patients who are still alive at the time of analysis, and who do not have Progressive Disease, duration of response will be censored at the date of the last objective progression-free disease assessment.

Phase 2 - Time to Disease Progression

Time to objective progressive disease (TTPD) is defined as the time from the date of study enrollment to the date of objectively determined Progressive Disease (PD). For patients who die without objective PD (including death from study disease), TTPD will be censored at the date of the last objective progression-free disease assessment. For patients who are still alive at the time of analysis, and who do not have PD, TTPD will be censored at the date of the last objective progression-free disease assessment.

Phase 2 - Time to Treatment Failure

Time to treatment failure (TTTF) is defined as the time from the date of study enrollment to the date of the first observation of disease progression, death from any cause, or early discontinuation of treatment (any reason). For patients who are alive, progression-free, and have not discontinued early at the time of analysis, TTTF will be censored at the date of the last objective progression-free disease assessment.

Phase 2 - Overall Survival

Overall survival is defined as the time from the date of study enrollment to the date of death from any cause. This analysis was not done due to the high number of censored patients.

Phase 2 - Number of Participants With Adverse Events (Toxicity)

A listing of adverse events is located in the Reported Adverse Event module.

Phase 2 - Progression-Free Survival

Progression-free survival (PFS) is defined as the time from the date of study enrollment to the date of objectively determined PD or death from any cause, whichever comes first. For patients who are still alive at the time of analysis, and who do not have PD, PFS will be censored at the date of the last objective progression-free disease assessment.

Full Information

NCT ID

NCT00489359

First Posted

June 19, 2007

Last Updated

May 17, 2011

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00489359

Brief Title

Trial of Pemetrexed and Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer

Official Title

A Phase 1 and 2 Clinical Trial of ALIMTA® (Pemetrexed) in Combination With Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

July 2005 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine efficacy of the combination therapy of pemetrexed and carboplatin as treatment for patients with platinum-sensitive ovarian cancer. This study also includes patients with primary peritoneal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer, Primary Peritoneal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

86 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pemetrexed/Carboplatin Phase 1

Arm Type

Experimental

Arm Description

Arm Title

Pemetrexed/Carboplatin Phase 2

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Pemetrexed - Phase 1

Other Intervention Name(s)

LY231514, Alimta

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Carboplatin - Phase 1

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Pemetrexed - Phase 2

Other Intervention Name(s)

LY231514, Alimta

Intervention Description

Dose determined from Phase 1: 500 mg/m^2, administered IV, every 21 days x 6 cycles

Intervention Type

Drug

Intervention Name(s)

Carboplatin - Phase 2

Intervention Description

Dose determined from Phase 1: AUC 6 mg/mL*min, administered IV, every 21 days x 6 cycles

Primary Outcome Measure Information:

Title

Phase 1 - Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Carboplatin

Description

Time Frame

First treatment to toxicity (up to 18 months)

Title

Phase 2 - Percentage of Participants With Overall Tumor Response (Response Rate)

Description

Time Frame

baseline to measured progressive disease (PD) (up to 18 months)

Secondary Outcome Measure Information:

Title

Phase 1 - Number of Dose-Limiting Toxicities (DLTs)

Description

Time Frame

baseline through end of Phase 1 (up to 18 months)

Title

Phase 1 - Number of Participants With Adverse Events (Toxicity)

Description

A listing of adverse events is located in the Reported Adverse Event module.

Time Frame

baseline measured to progressive disease (up to 18 months)

Title

Phase 1 - Recommended Dose of Pemetrexed for Phase 2

Description

Time Frame

baseline measured to progressive disease (up to 18 months)

Title

Phase 1 - Recommended Area Under the Curve (AUC) Dose of Carboplatin for Phase 2

Description

Time Frame

baseline measured to progressive disease (up to 18 months)

Title

Phase 1 - Number of Participants With Tumor Response

Description

Time Frame

baseline measured to progressive disease (up to 18 months)

Title

Phase 2 - Time to Response (TTR)

Description

Time Frame

First treatment to response (up to 31 months)

Title

Phase 2 - Duration of Response (DOR)

Description

Time Frame

time of response to progressive disease (up to 31 months)

Title

Phase 2 - Time to Disease Progression

Description

Time Frame

baseline to measured progressive disease (up to 31 months)

Title

Phase 2 - Time to Treatment Failure

Description

Time Frame

First treatment to discontinuation of study drug, progressive disease, or death (up to 31 months)

Title

Phase 2 - Overall Survival

Description

Overall survival is defined as the time from the date of study enrollment to the date of death from any cause. This analysis was not done due to the high number of censored patients.

Time Frame

baseline to date of death from any cause (up to 31 months)

Title

Phase 2 - Number of Participants With Adverse Events (Toxicity)

Description

A listing of adverse events is located in the Reported Adverse Event module.

Time Frame

baseline through end of Phase 2 (up to 31 months)

Title

Phase 2 - Progression-Free Survival

Description

Time Frame

baseline to measured progressive disease (up to 31 months)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of ovarian or primary peritoneal cancer confirmed by pathology 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: More than 2 lines of therapy for ovarian or primary peritoneal cancer. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Bahia Blanca

ZIP/Postal Code

B8000HXM

Country

Argentina

Facility Name

City

Buenos Aires

ZIP/Postal Code

C1199ACK

Country

Argentina

Facility Name

City

Ramos Mejia

ZIP/Postal Code

B1704ESN

Country

Argentina

Facility Name

City

Salta

ZIP/Postal Code

4400

Country

Argentina

Facility Name

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

City

Bonn

ZIP/Postal Code

53127

Country

Germany

Facility Name

City

Chemnitz

ZIP/Postal Code

D-09116

Country

Germany

Facility Name

City

Duesseldorf

ZIP/Postal Code

40489

Country

Germany

Facility Name

City

Erlangen

ZIP/Postal Code

D-91054

Country

Germany

Facility Name

City

Essen

ZIP/Postal Code

DE-45145

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

22081

Country

Germany

Facility Name

City

Jena

ZIP/Postal Code

D-07743

Country

Germany

Facility Name

City

Kiel

ZIP/Postal Code

D-24105

Country

Germany

Facility Name

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

City

Gdansk

ZIP/Postal Code

80-402

Country

Poland

Facility Name

City

Olsztyn

ZIP/Postal Code

10-228

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

00909

Country

Poland

Facility Name

City

Göteborg

ZIP/Postal Code

416 85

Country

Sweden

Facility Name

City

Lund

ZIP/Postal Code

22241

Country

Sweden

12. IPD Sharing Statement

Citations:

Citation

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.

Results Reference

background

PubMed Identifier

22044606

Citation

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.

Results Reference

derived

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Trial of Pemetrexed and Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer

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