Dalantercept in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

NCT01720173 | Completed Phase 2 Results DMC

• 6 other identifiers: GOG-0170RNCI-2012-01936NSC #757172CDR0000742512U10CA180868U10CA027469
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 40

Brief Summary

This phase II trial studies the side effects and how well dalantercept works in treating patients with ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer that has returned. Dalantercept may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Dalantercept may also stop the growth of tumor cells by blocking blood flow to the tumor.

Conditions

Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (3)

• Progression-free for at Least 6 Months Without Non-protocol Therapy From Study Entry

  Percentage of participants who survive progression-free for at least 6 months without non-protocol therapy after study entry. Progression is assessed by RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.

  Every other cycle for first 6 months

• Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0

  Number of participants with a maximum grade of 3 or higher during the treatment period.

  Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up

• Objective Tumor Response

  Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

  Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease, up to 5 years.

Secondary Outcomes (2)

• Overall Survival

  Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.

• Progression-free Survival

  Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease, up to 5 years.

Other Outcomes (3)

• Gene Expression Levels of ALK1 and Other Markers

  Baseline

• IHC Expression Levels of VEGF, FGF, TGFB, ALK1, CD105 and Other Markers

  Baseline

• Pre-treatment Plasma Concentration Levels of VEGF, BMP9, BMP10, and ALK1

  Baseline

Study Arms (1)

Treatment (dalantercept)

EXPERIMENTAL

Patients receive dalantercept SC on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Biological: Dalantercept; Other: Laboratory Biomarker Analysis

Interventions

Dalantercept BIOLOGICAL

Given SC

Also known as: ACE-041, Activin Receptor-like Kinase 1 Inhibitor ACE-041, ALK1-Fc Fusion Protein ACE-041

Treatment (dalantercept)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (dalantercept)

Eligibility Criteria

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

You may qualify if:

• Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report
• All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be \>= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or \>= 20 mm when measured by chest x-ray; lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI
• Patient must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
• Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG phase III protocol or Rare Tumor protocol for the same patient population
• Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2; patients who have received two prior regimens must have a GOG performance status of 0 or 1
• Recovery from effects of recent surgery, radiotherapy, or chemotherapy:
• Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection \[UTI\])
• 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 three weeks prior to registration; therapy with nitrosoureas or mitomycin must be discontinued at least six weeks prior to registration
• Any prior radiation therapy must be discontinued at least four weeks prior to registration
• At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: laparotomy, laparoscopy); there is no delay in treatment for minor procedures (e.g., central venous access catheter placement)
• Prior therapy:
• Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, biologic/targeted (non-cytotoxic) agents (e.g., bevacizumab) or extended therapy administered after surgical or non-surgical assessment
• Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease
• Patients who have received only one prior cytotoxic regimen (platinum-based regimen for management of primary disease), must have a platinum-free interval of less than 12 months, or have progressed during platinum-based therapy, or have persistent disease after a platinum-based therapy

You may not qualify if:

• Patients who have had previous treatment with dalantercept or any other anti-ALK1 (activin receptor-like kinase 1) agent
• Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies, are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
• Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
• Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
• Patients with a past history of primary endometrial cancer are excluded unless all of the following conditions are met: stage not greater than I-B; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serious, clear cell or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
• Patients with history or evidence upon physical exam of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy or any brain metastases
• Serious or non-healing wound, ulcer or bone fracture
• History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months
• Patients requiring parenteral hydration or parenteral/total parenteral nutrition
• Patients with:
• Active bleeding (e.g., active hemoptysis, defined as bright red blood of greater than or equal to 1/2 teaspoon \[2.5 ml\] in any 24 hour period within 2 weeks prior to registration or gastrointestinal bleeding within 3 months prior to registration)
• Hereditary hemorrhagic telangiectasia (HHT)
• Platelet function abnormality
• Autoimmune or hereditary hemolysis
• Coagulopathy

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (40)

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

The Hospital of Central Connecticut

New Britain, Connecticut, 06050, United States

Location

Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, 31405, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Maine Medical Center-Bramhall Campus

Portland, Maine, 04102, United States

Location

Christiana Care - Union Hospital

Elkton, Maryland, 21921, United States

Location

UMass Memorial Medical Center - Memorial Division

Worcester, Massachusetts, 01605, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87102, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, 44124, United States

Location

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, 44060, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Jefferson Abington Hospital

Abington, Pennsylvania, 19001, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104, United States

Location

Sanford NCI Community Oncology Research Program of the North Central Plains

Sioux Falls, South Dakota, 57104, United States

Location

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

Location

The Don and Sybil Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

Pacific Gynecology Specialists

Seattle, Washington, 98104, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

University of Washington Medical Center - Northwest

Seattle, Washington, 98133, United States

Location

University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States

Location

Green Bay Oncology at Saint Vincent Hospital

Green Bay, Wisconsin, 54301-3526, United States

Location

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Green Bay Oncology Limited at Saint Mary's Hospital

Green Bay, Wisconsin, 54303, United States

Location

Holy Family Memorial Hospital

Manitowoc, Wisconsin, 54221, United States

Location

Bay Area Medical Center

Marinette, Wisconsin, 54143, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

ALK1-Fc fusion protein, human

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: Angela Kuras on behalf of Wei Deng, PhD
• Organization: NRG Oncology

kurasa@nrgoncology.org

716-845-5702

Study Officials

• Robert A Burger

  NRG Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: October 30, 2012
• First Posted: November 2, 2012
• Study Start: November 5, 2012
• Primary Completion: October 31, 2015
• Study Completion: February 19, 2019
• Last Updated: October 20, 2021
• Results First Posted: December 8, 2017

Record last verified: 2021-09

Locations

US (40)