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Completed

NCT Number: NCT00420381

Evaluation of Enzastaurin in the Treatment of Persistent or Recurrent Ovarian or Primary Peritoneal Cancer

The purpose is to assess the efficacy and toxicity of the study agent, enzastaurin, in participants with recurrent or persistent ovarian cancer.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Carcinoma Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Gynecologic Oncology Group 215-854-0770

Philadelphia, Pennsylvania, 19103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have recurrent or persistent epithelial ovarian or primary peritoneal carcinoma.
  • All participants must have measurable disease.
  • Participants must have at least one "target lesion" to be used to assess response on this protocol.
  • Participants must not be eligible for a higher priority GOG protocol, if one exists.
  • Participants who have received one prior regimen must have a GOG Performance Status of 0, 1, or 2. Participants who have received two prior regimens must have a GOG Performance Status of 0 or 1.
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted.
  • Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least four weeks prior to registration.
  • Participants must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound.
  • Participants must NOT have received any non-cytotoxic therapy for management of recurrent or persistent disease.
  • Participants of child-bearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after discontinuation of study treatment.

Exclusion criteria

  • Participants with previous enzastaurin treatment.
  • Participants who have received radiation to more than 25% of marrow-bearing areas
  • Participants with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.
  • Participants who 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.
  • Participants who are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin (refer to Concomitant Medications for a discussion of enzyme inducing anti-epileptic drugs [EIAEDs]).
  • Participants who are receiving concurrent administration of any other systemic anticancer therapy except for a biphosphonate if patient has bony metastases.
  • Participants who have received prior therapy with non-cytotoxic agents (i.e. bevacizumab).
  • Participants with serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study.

Treatment and study plan

enzastaurin

Drug

1125 mg loading dose then 500 mg, oral, daily, until progressive disease

Other names: LY317615

Primary outcomes

  1. Progression-free Survival for at Least 6 Months (PFS-6)

    Time frame: Baseline through 6 months

    Data presented are the percentage of participants without progressive disease (PD) or death from any cause 6 months after registration. PD was a 25% increase in the sum of products of all measurable lesions (or 2 largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).

  2. Number of Participants With Adverse Events and Severe Adverse Events

    Time frame: Baseline through end of study (Up to 45 months)

    Data presented are the number of participants who experienced 1 or more adverse events (AEs) (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.

Secondary outcomes

  1. Duration of Progression-Free Survival

    Time frame: Baseline to disease progression (Up to 38 months)

    PFS is defined as the rate of PFS from the date of diagnosis to the first date of objectively determined progressive disease (based on radiological assessment) or death from any cause. It is assumed that PFS follows an exponential distribution.

  2. Prognostic Factors: Platinum Sensitivity

    Time frame: Baseline

    Participants who had disease progression within 6 months of ending their last regimen of platinum therapy were considered platinum resistant. Participants who had disease progression between 6 and 12 months of ending their last platinum regimen were considered platinum sensitive. Participants who had disease progression beyond 12 months of ending their last platinum regimen were also considered platinum sensitive.

  3. Prognostic Factors: Performance Status

    Time frame: Baseline

    Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work.

  4. Overall Survival

    Time frame: Baseline through end of study (Up to 45 months)

    Overall survival (OS) time is defined as the time from the date of diagnosis to the date of death from any cause. For participants who are still alive at the time of analysis, survival time will be censored at the last contact date.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Gynecologic Oncology Group

Registry information

Official study title

A Phase II Evaluation of Enzastaurin in the Treatment of Persistent or Recurrent Ovarian or Primary Peritoneal Carcinoma

Important dates

Study start
2007
Primary completion
2008
Study completion
2014
First posted
Jan 11, 2007
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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