Conatumumab, Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer

NCT01017822 | Withdrawn Phase 1 DMC

• 2 other identifiers: RTOG-0932CDR0000659527
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Monoclonal antibodies, such as conatumumab, 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 hydrochloride and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy may uses high energy x-rays to kill tumor cells. Giving conatumumab together with gemcitabine hydrochloride, capecitabine, and radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of conatumumab when given together with gemcitabine hydrochloride, capecitabine, and radiation therapy and to see how well they work in treating patients with locally advanced pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage III pancreatic cancer

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (Phase I)

• Overall survival (Phase II)

Secondary Outcomes (3)

• Adverse events (Phase I and II)

• Progression-free survival (Phase II)

• Response rate (Phase II)

Interventions

conatumumab BIOLOGICAL

capecitabine DRUG

gemcitabine hydrochloride DRUG

3-dimensional conformal radiation therapy RADIATION

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 * Locally advanced disease * With and without regional adenopathy * Unresectable disease based on institutional standardized criteria of unresectability OR medically inoperable * No distant metastatic disease, second malignancy, or peritoneal seeding PATIENT CHARACTERISTICS: * Zubrod performance status 0-1 * Absolute granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed) * Serum creatinine ≤ 1.5 mg/dL * ALT or AST \< 3 times upper limit of normal (ULN) * Total bilirubin \< 3.0 mg/dL * Alkaline phosphatase \< 3 times ULN * Amylase ≤ 2 times ULN * Lipase ≤ 2 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 3 months after the last study drug administration (for women) or for ≥ 6 months after the last study drug administration (for men) * Able to swallow oral medications * No other invasive malignancy within the past 2 years, except for nonmelanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix * No severe, active co-morbidity, including any of the following: * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within the past 30 days * Transmural myocardial infarction within the past 3 months * Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months * Any other cardiac condition that, in the opinion of the treating physician, would make study treatment unreasonably hazardous for the patient * Acute bacterial or fungal infection requiring IV antibiotics * Uncontrolled malabsorption syndrome significantly affecting gastrointestinal function * Any unresolved bowel or bile duct obstruction * Major resection of the stomach or small bowel that could affect the absorption of capecitabine * AIDS based upon current CDC definition * HIV testing is not required for study entry * No prior allergic reaction to capecitabine or gemcitabine hydrochloride PRIOR CONCURRENT THERAPY: * No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields * No prior treatment with TRAIL-receptor agonists * No prior systemic chemotherapy for pancreatic cancer * More than 2 years since prior chemotherapy for malignancies other than pancreatic cancer * More than 28 days since prior major surgery (e.g., biliary or gastric bypass) * Insertion of a vascular access device, exploratory laparotomy, or laparoscopy are not considered major surgery * No concurrent intensity-modulated radiotherapy * No other concurrent chemotherapy * No other concurrent monoclonal antibody therapy * No concurrent sorivudine, brivudine A, or cimetidine * No concurrent participation in another clinical trial * Concurrent oral anticoagulants (e.g., warfarin) allowed provided INR is monitored

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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

conatumumab; Capecitabine; Gemcitabine; Radiotherapy, Conformal

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Christopher H. Crane, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2009
• First Posted: November 23, 2009
• Last Updated: June 24, 2013

Record last verified: 2013-06