Monoclonal Antibody RAV12 and Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer

NCT00625586 | Terminated Phase 2 Results

• 2 other identifiers: CDR0000587562RAVENBIO-RV12-2007-003
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Monoclonal antibodies, such as RAV12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving RAV12 together with gemcitabine may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and best dose of monoclonal antibody RAV12 when given together with gemcitabine in treating patients with metastatic pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage IV pancreatic cancer; recurrent pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients Alive at 8 Months

  8 months

Secondary Outcomes (6)

• Number of Patients Alive at 12 Months

  12 months

• Partial Response and Complete Response Rates

  8 months

• Median Progression-free Survival

  up to 11 months

• Median Overall Survival

  up to 11 months

• Participants With Adverse Events

  Throughout the study, up to 11 months

Study Arms (1)

RAV12 plus gemcitabine

EXPERIMENTAL

Biological: RAV12; Drug: Gemcitabine

Interventions

RAV12 BIOLOGICAL

RAV12 at 0.375 mg/kg weekly escalated to 0.75 mg/kg weekly, intravenously.

RAV12 plus gemcitabine

Gemcitabine DRUG

1000 mg/m2 weekly, intravenously

Also known as: Gemzar

RAV12 plus gemcitabine

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the pancreas * Metastatic disease * No prior therapy for metastatic disease (except prior adjuvant chemotherapy and/or radiotherapy) * At least 1 radiographically measurable site of disease ≥ 2 cm in the largest dimension by traditional CT technique or ≥ 1 cm by spiral CT scan (per RECIST) * No known history of current or prior central nervous system (CNS) metastatic disease PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group performance status 0-2 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9.0 g/dL * alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times upper limit of normal (ULN) * Alkaline phosphatase and γ-glutamyltransferase ≤ 2.5 times ULN * Amylase and lipase ≤ 1.5 times ULN * Total bilirubin ≤ 1.5 times ULN * Creatinine \< 1.5 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Must be available for study-related treatments and assessments at the treating institution * No known hypersensitivity to any component of gemcitabine hydrochloride * No known hypersensitivity to murine or recombinant proteins, polysorbate 80, or any excipient contained in the drug formulation * No other primary malignancy that has been in remission for ≤ 3 years except treated nonmelanoma skin cancer, biopsy-confirmed carcinoma in situ of the cervix, squamous intraepithelial lesion on Papanicolaou smear, localized prostate cancer with Gleason score \< 6, or resected melanoma in situ * No other primary malignancy that has a generally accepted recurrence risk ≥ 10% * No active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 4 weeks of enrollment * No history of chronic or recurrent infections that require continuous use of antiviral, antifungal, or antibacterial agents * No serious underlying medical condition that would impair the patient's ability to receive or tolerate the planned treatment at the investigational site, including significant pulmonary compromise or heart disease of New York Heart Association class III or IV * No dementia or altered mental status that would preclude sufficient understanding to provide informed consent PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 4 weeks since prior major surgery * More than 4 weeks since prior and no other concurrent investigational agents * More than 1 week since prior oral antiviral, antifungal, or antibacterial therapy * No concurrent immunosuppressive medications, steroids (except steroid inhaler, ophthalmic solution, nasal spray, or a stable dose of ≤ 10 mg/day of oral prednisone or equivalent), other antineoplastic therapy, or antitumor vaccinations * Monoclonal antibody treatment for non-cancer indications must be completed at least 3 half lives from study entry * No concurrent prophylactic hematologic growth factors * No concurrent megavitamin therapy * No concurrent bisphosphonates

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• MacroGenics: lead

Study Sites (2)

MacroGenics, Incorporated

South San Francisco, California, 94080, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Chief Medical Officer
• Organization: MacroGenics, Inc.

info@macrogenics.com

301-251-5172

Study Officials

• Stanford Stewart, MD

  MacroGenics, Incorporated

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: February 26, 2008
• First Posted: February 28, 2008
• Study Start: April 15, 2008
• Primary Completion: January 21, 2009
• Study Completion: March 18, 2009
• Last Updated: November 3, 2023
• Results First Posted: December 19, 2012

Record last verified: 2023-10

Locations

US (2)