NCT00191646

Brief Summary

This is a phase III randomized study comparing induction treatments of Gemcitabine and Carboplatin versus Paclitaxel and Carboplatin, with or without consolidation therapy for patients that do not have any evidence of disease after completion of six cycles of induction therapy. Patients with disease after induction therapy will crossover to receive single agent therapy.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
919

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_3

Geographic Reach
2 countries

55 active sites

Status
completed

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

October 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 9, 2010

Completed
Last Updated

March 4, 2011

Status Verified

February 1, 2011

Enrollment Period

6.8 years

First QC Date

September 12, 2005

Results QC Date

August 12, 2010

Last Update Submit

February 28, 2011

Conditions

Genital Neoplasms, FemaleFallopian Tube NeoplasmsOvarian NeoplasmsPelvic NeoplasmsPeritoneal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival (PFS)

    Progression free survival was defined as the duration from the date of randomization to the first date of documented disease progression or death from any cause. Tumor assessments were performed every three 21-day cycles during induction and crossover. Progression free survival was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.

    Baseline to measured progressive disease or death up to 82 months

Secondary Outcomes (3)

  • Proportion of Participants With Response (Response Rate)

    Baseline to measured progressive disease up to 82 months

  • Time to Treatment Failure

    Baseline to stopping treatment up to 82 months

  • Overall Survival

    Baseline to death from any cause up to 82 months

Study Arms (2)

Gemcitabine/Carboplatin

EXPERIMENTAL

Gemcitabine 1000 milligrams per meter square (mg/m\^2) Day 1 and Day 8, Carboplatin Area Under the Curve (AUC) 5 Day 1, six 21-day cycles

Drug: GemcitabineDrug: Carboplatin

Paclitaxel/Carboplatin

ACTIVE COMPARATOR

Paclitaxel 175 milligrams per meter square (mg/m\^2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, six 21 day cycles

Drug: PaclitaxelDrug: Carboplatin

Interventions

GemcitabineDRUG

1000 mg/m\^2, Intravenously (IV), day 1 and day 8 every (q) 21 days x 6 cycles If anything other than complete response in Paclitaxel arm patients, 1000 mg/m\^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity

Also known as: LY188011, Gemzar
Gemcitabine/Carboplatin
PaclitaxelDRUG

175 mg/m\^2, IV, Day 1, q 21 days x 6 cycles If complete response both Paclitaxel and Gemcitabine arms may elect to receive consolidation therapy, 135 mg/m\^2, IV, 3 hours q 28 days x 12 cycles (1 year) If no complete response, then Gemcitabine arm patients may receive 175 mg/m\^2, IV, Day 1, q 21 days until complete response, disease progression or unacceptable toxicity

Paclitaxel/Carboplatin
CarboplatinDRUG

Gemcitabine/Carboplatin AUC 5, IV, Day 1, q 21 days x 6 cycles Paclitaxel/Carboplatin AUC 6, IV, Day 1, q 21 days x 6 cycles

Gemcitabine/CarboplatinPaclitaxel/Carboplatin

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a histologic diagnosis of primary peritoneal carcinoma, epithelial ovarian carcinoma or fallopian tube carcinoma Stage IC, II, III or IV.
  • All patients must have had surgery for fallopian, ovarian or peritoneal carcinoma to establish the diagnosis and have tissue available for histologic evaluation and confirmation of organ of origin.
  • Patients must be enrolled no more than twelve weeks postoperatively.
  • Patients must be willing to receive their chemotherapy drugs intravenously, as intraperitoneal therapy is not part of this trial.

You may not qualify if:

  • Patients with a current diagnosis of epithelial ovarian tumor of low malignant potential (Borderline carcinomas) are not eligible.
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded
  • With the exception of non-melanoma skin cancer and other specific malignancies patients who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (55)

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.

Phoenix, Arizona, 85006, United States

Location

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Little Rock, Arkansas, 72205, United States

Location

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Los Gatos, California, 95032, United States

Location

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Modesto, California, 95350, United States

Location

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San Diego, California, 92121, United States

Location

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Englewood, Colorado, 80113, United States

Location

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Newark, Delaware, 19713, United States

Location

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Fort Myers, Florida, 33901, United States

Location

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South Miami, Florida, 33143, United States

Location

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Sunrise, Florida, 33323, United States

Location

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Atlanta, Georgia, 30342, United States

Location

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Savannah, Georgia, 31404, United States

Location

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Palatine, Illinois, 60067, United States

Location

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Indianapolis, Indiana, 46260, United States

Location

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South Bend, Indiana, 46617, United States

Location

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Metairie, Louisiana, 70006, United States

Location

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New Orleans, Louisiana, 70121, United States

Location

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Scarborough, Maine, 04074, United States

Location

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Detroit, Michigan, 48201, United States

Location

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Grand Rapids, Michigan, 49546, United States

Location

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Duluth, Minnesota, 55805, United States

Location

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Minneapolis, Minnesota, 55455, United States

Location

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Rochester, Minnesota, 55905, United States

Location

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Kansas City, Missouri, 64111, United States

Location

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St Louis, Missouri, 63141, United States

Location

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Billings, Montana, 59107, United States

Location

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Las Vegas, Nevada, 89109, United States

Location

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Reno, Nevada, 89502, United States

Location

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Hackensack, New Jersey, 07601, United States

Location

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Rochester, New York, 14620, United States

Location

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Chapel Hill, North Carolina, 27599, United States

Location

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Charlotte, North Carolina, 28204, United States

Location

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Durham, North Carolina, 27710, United States

Location

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Greenville, North Carolina, 27858, United States

Location

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Columbus, Ohio, 43222, United States

Location

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Dayton, Ohio, 45429, United States

Location

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Oklahoma City, Oklahoma, 73112, United States

Location

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Dunmore, Pennsylvania, 18512, United States

Location

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Johnstown, Pennsylvania, 15905, United States

Location

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Pittsburgh, Pennsylvania, 15224, United States

Location

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Sayre, Pennsylvania, 18840, United States

Location

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Providence, Rhode Island, 02905, United States

Location

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Charleston, South Carolina, 29425, United States

Location

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Columbia, South Carolina, 29210, United States

Location

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Greenville, South Carolina, 29601, United States

Location

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Chattanooga, Tennessee, 37404, United States

Location

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Knoxville, Tennessee, 37920, United States

Location

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Memphis, Tennessee, 38120, United States

Location

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Austin, Texas, 78735, United States

Location

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Lubbock, Texas, 79410, United States

Location

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Salt Lake City, Utah, 84106, United States

Location

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Roanoke, Virginia, 24014, United States

Location

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Seattle, Washington, 98104, United States

Location

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Madison, Wisconsin, 53792, United States

Location

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San Juan, 009362712, Puerto Rico

Location

MeSH Terms

Conditions

Genital Neoplasms, FemaleFallopian Tube NeoplasmsOvarian NeoplasmsPelvic NeoplasmsPeritoneal Neoplasms

Interventions

GemcitabinePaclitaxelCarboplatin

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesFallopian Tube DiseasesAdnexal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersAbdominal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesPeritoneal Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Limitations and Caveats

Trial was designed with overall survival as primary endpoint. Enrollment was slower than expected. After 4 years, 919 patients were randomized and in August 2006, protocol was amended: primary endpoint was changed to progression free survival (PFS).

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) OR 1-317-615-4559 MON-FRI 9AM -5PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

October 1, 2002

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

March 4, 2011

Results First Posted

September 9, 2010

Record last verified: 2011-02

Locations

US(54)PR(1)