Determine if Either of 2 Doses of Study Drug Given With a Low-dose of Cyclophosphamide After a Complete or Partial Response to a Platinum-based Second-line Therapy in Women With Recurrent Ovarian Carcinoma Results in a Longer Time to Progression When Compared to the First Time to Progression.

NCT00408967 | Withdrawn Phase 2

• 1 other identifier: EMR 62206-016
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if either of two doses of EMD 273066 when given with a low dose of cyclophosphamide will result in a second time to progression that is as long or longer than the first time to progression

Conditions

Ovarian Cancer

Keywords

Ovarian; Cancer; Epithelial; Recurrent; Platinum; Second-line therapy; Maintenance Therapy; Biologic; Targeted Therapy; Antibody

Study Arms (1)

Tucotuzumab celmoleukin (EMD 273066)

EXPERIMENTAL

Drug: Tucotuzumab celmoleukin (EMD 273066)

Interventions

Tucotuzumab celmoleukin (EMD 273066) DRUG

Tucotuzumab celmoleukin (EMD 273066)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• Age 18 years or older
• Have histologically documented ovarian carcinoma (including primary peritoneal carcinoma)
• Have archival tumor tissue available for EpCAM expression determination by immunohistochemistry
• Received first-line platinum-based chemotherapy of up to 8 cycles (approximately 15 to 24 weeks)
• Experienced a complete response to first-line platinum-based chemotherapy
• Experienced a platinum-free interval of at least 6 but not more than 24 months starting at the end of the last cycle of first-line chemotherapy until recurrence
• Treatment with Avastin (bevacizumab) is permitted during first-line platinum-based chemotherapy through TTP and platinum-based reinduction therapy up to 28 days prior to start of EMD 273066
• Experienced a partial or complete response after up to 8 cycles of second-line platinum-based chemotherapy
• Have a CT/MRI scan within 4 weeks prior to starting treatment
• Be able to start cyclophosphamide and EMD 273066 treatment within 3 to 5 weeks of completion of second-line chemotherapy
• KPS ≥70%
• No clinical history of significantly impaired renal function or chronic kidney disease. Must have an estimated glomerular filtration rate ≥50 mL/min determined by the Cockgroft-Gault-formula
• WBC count ≥2.5x10³/µL (or total granulocytes ≥1x10³/µL)
• Absolute lymphocyte count (ALC) ≥0.5x103/µL

You may not qualify if:

• Dyspnea at rest, exercise intolerance
• In any subject with clinically significant non-malignant pulmonary disease: Pulmonary function testing (to include Forced Vital Capacity \[FVC\] and 1-second Forced Expiratory Volume \[FEV-1\]) showing \<70% of predicted values for FVC or FEV-1 and/or DLCO \<50%.
• In any subject with pulmonary or pleural metastatic disease: Arterial oxygen saturation at rest measured transcutaneously on room air \< 90% or increased risk for respiratory compromise related to IL2 exposure in the judgment of the investigator.
• ECG with evidence of clinically significant disease within 4 weeks prior to starting study treatment
• Cardiac stress test (e.g., exercise or pharmacological thallium test; exercise or pharmacological echocardiography) with abnormal results within 4 weeks prior to starting treatment in subjects who have a history of coronary heart disease (myocardial infarction, angina pectoris or pathologic coronary angiography)
• Any current evidence of congestive heart failure with NY Heart Association Grade 2 through 4 or echocardiogram with a left ventricular ejection fraction \<45% or other signs of clinical significant heart disease
• History of repeated and clinically relevant episodes of syncope or other paroxysmal, ventricular, or other clinically significant arrhythmias
• Evidence of active brain metastases
• Previous malignancy other than ovarian cancer in the last 5 years except basal cell cancer of the skin or pre-invasive cancer of the cervix
• Pregnant or lactating female
• An immediate need for palliative radiotherapy or systemic corticosteroid therapy
• Significant active infection
• Major surgery, chemotherapy, or radiation within 21 days of starting study treatment
• Received another experimental drug within 28 days of starting study treatment
• Uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg) or hypotension (systolic ≤90 mmHg)

Sponsors & Collaborators

• EMD Serono: lead

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplasms; Recurrence

Interventions

tucotuzumab celmoleukin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Responsible

  Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2006
• First Posted: December 8, 2006
• Study Start: December 31, 2006
• Primary Completion: May 31, 2008
• Study Completion: May 31, 2008
• Last Updated: August 18, 2017

Record last verified: 2017-08