Phase 1-2 Vatalanib and Gemcitabine in Advanced Pancreatic Cancer

NCT00185588 | Completed Phase 1 Results DMC

• 4 other identifiers: IRB-0699995533CPTK787AUS08PANC0002
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the optimal safe and tolerable dose of gemcitabine in combination with once daily or twice daily dose of PTK/ZK in patients with unresectable pancreatic cancer. The Phase II part of this study planned to determine the antitumor activity of this regimen and its effectiveness of preventing tumor growth and spread.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Time-to-Treatment Failure (Intent-To-Treat Analysis)

  For the purposes of an Intent-to-Treat (ITT) analysis, Time-to-Treatment Failure (TTF) was defined as the time from treatment initiation to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, lost-to-follow-up, or death. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).

  12 months

Secondary Outcomes (1)

• Time-to-Progression, Evaluable Patients

  12 months

Study Arms (4)

Stage 1 Dose Exploration 0 - Gemcitabine 700 + vatalanib 1250

EXPERIMENTAL

Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily

Drug: Vatalanib; Drug: Gemcitabine

Stage 1 Dose Exploration 1 - Gemcitabine 850 + vatalanib 1250

EXPERIMENTAL

Gemcitabine 850 mg/m2 + vatalanib 1250 mg

Drug: Vatalanib; Drug: Gemcitabine

Stage 1 Dose Explrtion2 - Gemcitabine850+vatalanib 2x250/2x500

EXPERIMENTAL

Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter

Drug: Vatalanib; Drug: Gemcitabine

Stage 2 Dose Expansion - Gemcitabine850+vatalanib 2x250/2x500

EXPERIMENTAL

Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter

Drug: Vatalanib; Drug: Gemcitabine

Interventions

Vatalanib DRUG

Vatalanib 250 mg PO Q12 hours x 7 days, 8th day forward 500 mg PO Q12 hours

Also known as: PTK787, ZK 222584, PTK787/ZK 222584

Stage 1 Dose Exploration 0 - Gemcitabine 700 + vatalanib 1250; Stage 1 Dose Exploration 1 - Gemcitabine 850 + vatalanib 1250; Stage 1 Dose Explrtion2 - Gemcitabine850+vatalanib 2x250/2x500; Stage 2 Dose Expansion - Gemcitabine850+vatalanib 2x250/2x500

Gemcitabine DRUG

850 mg/m2

Also known as: Gemzar

Stage 1 Dose Exploration 0 - Gemcitabine 700 + vatalanib 1250; Stage 1 Dose Exploration 1 - Gemcitabine 850 + vatalanib 1250; Stage 1 Dose Explrtion2 - Gemcitabine850+vatalanib 2x250/2x500; Stage 2 Dose Expansion - Gemcitabine850+vatalanib 2x250/2x500

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas
• Unresectable (due to involvement of critical vasculature, adjacent organ invasion, or presence of metastasis)
• If \> 5 years between the primary surgery and the development of metastatic disease, then separate histological or cytological confirmation of metastatic disease
• Primary or metastatic lesion within 4 weeks prior to entry of study
• WHO performance status of 0 to 2
• ≤ 18 years of age
• Absolute Neutrophil Count (ANC) ≥ 1.5 x 10e9/L (\>= 1500/mm3)
• Platelets (PLT) ≥ 100 x 10\^9/L (≥ 100,000/mm3)
• Hemoglobin (Hgb) ≥ 9 g/dL
• Serum creatinine ≤ 1.5 upper limit of normal (ULN)
• Serum bilirubin ≤ 1.5 ULN
• Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase
• (ALT/SGPT) ≤ 3.0 x ULN OR
• ≤ 5 x ULN if liver metastases present
• Proteinuria:

You may not qualify if:

• For the "phase 1" portion of the study: prior gemcitabine will be therapy.
• For the "phase 2" portion of the study: any prior chemotherapy {except for low-dose 5-fluorouracil (5-FU)as a radiosensitizer\]
• Radiotherapy (RT). The site of previous RT must have progressive disease if the only site of disease).
• Prior full field radiotherapy ≤ 4 weeks prior to enrollment OR
• Limited field radiotherapy ≤ 2 weeks prior to enrollment. Patients must have recovered from all therapy-related toxicities.
• Prior biologic or immunotherapy ≤ 2 weeks prior to registration.
• Prior therapy with anti-VEGF agents
• History or presence of central nervous system (CNS) disease
• Patients with a history of another primary malignancy ≤ 5 years (Exception: inactive basal or squamous cell carcinoma of the skin)
• Major surgery ≤ 4 weeks prior to enrollment. (Exception: insertion of a vascular access device)
• Minor surgery ≤ 2 weeks prior to enrollment. (Exception: insertion of a vascular access device)
• Concurrent use of other investigational agents and patients who have received investigational drugs ≤ 4 weeks prior to enrollment.
• Pregnant, or breast-feeding, not employing an effective method of birth control.
• Pre-existing peripheral sensory neuropathy with functional impairment (≥ CTCAE grade 2 neuropathy)
• Respiratory compromise due to pleural effusion or ascites (≥ CTCAE grade 2 dyspnea)

Sponsors & Collaborators

• George Albert Fisher: lead
• Novartis: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

vatalanib; 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: George Albert Fisher, Associate Professor of Medicine, Stanford University
• Organization: Stanford University

georgeaf@stanford.edu

650-725-9057

Study Officials

• George Albert Fisher M.D. Ph.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: October 1, 2004
• Primary Completion: January 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 15, 2014
• Results First Posted: September 15, 2014

Record last verified: 2014-09

Locations

US (1)