Safety and Efficacy Study of P276-00 in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer

NCT00898287 | Completed Phase 1 DMC

• 1 other identifier: P276-00/28/08
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to identify a dose of P276-00 that can be safely administered along with Gemcitabine and to examine safety and efficacy of the combination in treatment of advanced pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

Locally advanced or metastatic adenocarcinoma of pancreas

Outcome Measures

Primary Outcomes (1)

• To determine the maximum tolerated dose (MTD) of P276-00 administered along with Gemcitabine.

  3 weeks

Secondary Outcomes (4)

• To evaluate pharmacokinetic parameters of P276-00.

  one week

• To determine clinical benefit response to P276-00 in combination with Gemcitabine in patients with cancer of pancreas.

  Every week

• To determine objective tumor response rate to P276-00 in combination with Gemcitabine in patients with cancer of pancreas.

  Every 6 weeks

• To characterize toxicities of P276-00 in combination with Gemcitabine.

  Every week

Study Arms (1)

P276-00 plus Gemcitabine

EXPERIMENTAL

Subjects will be enrolled at different levels of P276-00 dosage as follows:- Level 1 - 100mg/m2/day x 5 q 3 weeks Level 2 - 140 mg/m2/day x 5 q 3 weeks Level 3 - 185 mg/m2/day x 5 q 3 weeks P276-00 will be administered as intravenous infusion in 200 ml of 5% dextrose over 30min from days 1 to 5 per 21 day cycle. Six such cycles will be administered unless there is progression of disease or unacceptable toxicity. Gemcitabine will be administered as an intravenous infusion at dose of 1000mg/m2 over 30 mins every week for 7 weeks followed by a gap of one week and then 3 weekly doses every 4 weeks. This treatment will be continued for six P276-00 cycles of 3 weeks each unless there is progression of disease or unacceptable toxicity.

Drug: P276-00; Drug: Gemcitabine

Interventions

P276-00 DRUG

Subjects will be enrolled at different levels of P276-00 dosage as follows:- Level 1 - 100mg/ m 2/day x 5 q 3 weeks Level 2 - 140 mg/ m2/day x 5 q 3 weeks Level 3 - 185 mg/ m2 /day x 5 q 3 weeks P276-00 will be administered as intravenous infusion in 200 ml of 5% dextrose over 30min from days 1 to 5 per 21 day cycle. Six such cycles will be administered unless there is progression of disease or unacceptable toxicity.

P276-00 plus Gemcitabine

Gemcitabine DRUG

Gemcitabine will be administered as an intravenous infusion at dose of 1000mg/m 2 over 30 mins every week for 7 weeks followed by a gap of one week and then 3 weekly doses every 4 weeks. This treatment will be continued for six P276-00 cycles of 3 weeks each unless there is progression of disease or unacceptable toxicity.

P276-00 plus Gemcitabine

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 diagnosis of infiltrating ductal adenocarcinoma of pancreas.
• Chemonaive patients i.e. patients must not have received chemotherapy or biologic/targeted anticancer therapy for the adenocarcinoma of pancreas.
• Locally advanced inoperable pancreatic cancer.
• Patients of either sex, aged \> or = 18 years.
• Karnofsky performance status of \> or = 60%.
• Adequate bone marrow reserve: white blood cell (WBC) count \> or = 4 x 109/l, Absolute neutrophil count (ANC) ≥ 1.5 x 109/l, platelets \> or = 100 x 109/l, hemoglobin \> or = 10 g/dl.
• Adequate liver function: bilirubin \< or = 1.5 times the upper normal value, ALT/AST/ alkaline phosphatase less than 3 times the upper normal value (unless due to liver metastases in which case bilirubin less than 3 times the upper normal value, ALT/AST less than 4 times the upper normal value, and alkaline phosphatase without limit).
• Adequate renal function: creatinine ≤ 1.5 times the upper normal value.
• If female:
• Childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of at least 2 approved contraceptive methods (at least one should be a barrier method) during and for 4 weeks after stopping the study treatment.
• Negative urine β-HCG test within 1 week prior to protocol entry where childbearing potential is not terminated.
• Karnofsky performance status of 60 or 70
• Baseline pain intensity score of \> or = 20 mm

You may not qualify if:

• Inability / unwillingness to give consent.
• Pregnant or breast feeding women.
• Brain metastasis (active or inactive).
• Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
• Patients known to be suffering from infection with HIV, Hepatitis C or Hepatitis B.
• Patients who had received any other investigational drug within 1 month prior to Day 1 of protocol treatment.
• Patients with QTc \> 450 msec on 12-lead standard electrocardiogram (ECG).
• Major surgery within 2 weeks prior to protocol treatment.
• Radiotherapy to \> 10% of bone marrow.
• Patients with 3rd space fluid accumulation (ascites, pleural effusion).

Sponsors & Collaborators

• Piramal Enterprises Limited: lead

Study Sites (7)

Central India Cancer Research Institute

Nagpur, Ajayonco@hotmail.com, 440 010, India

Location

Global Hospital

Hyderabaad, Andhra Pradesh, 500004, India

Location

Curie Manavata Cancer Centre

Nashik, Maharashtra, 422 004, India

Location

Deenanath Mangeshkar Hospital & Research Centre

Pune, Maharashtra, 411004, India

Location

Sri RamaChandra Medical Centre

Chennai, Tamil Nadu, 600 116, India

Location

Lifeline Mutispecilaity Hospital

Chennai, Tamil Nadu, 600096, India

Location

Meenakshi Mission Hospital & Reasearch Centre

Madurai, Tamil Nadu, 625107, India

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

P276-00; 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

Study Officials

• Amol Bapaye, MS

  Deenanath Mangeshkar Hospital & Research Centre, ,Pune, India

  PRINCIPAL INVESTIGATOR

• Raj Nagarkar, MS

  Curie Manavata Cancer Centre, Nashik, India

  PRINCIPAL INVESTIGATOR

• J S Rajkumar, DNB

  Lifeline Mutispecilaity Hospital, Chennai, India

  PRINCIPAL INVESTIGATOR

• Ravi K Saxena, DNB

  Global Hospital, Hyderabad, India.

  PRINCIPAL INVESTIGATOR

• Kirushna Kumar, MD

  Meenakshi Mission Hospital & Reasearch Centre, Madurai, India

  PRINCIPAL INVESTIGATOR

• Anita Ramesh, MD

  Sri RamaChandra Medical Centre, Chennai, India

  PRINCIPAL INVESTIGATOR

• Ajay Mehta, MS

  Central India cancer Research Institute, Nagpur, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2009
• First Posted: May 12, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2010
• Last Updated: January 20, 2012

Record last verified: 2012-01

Locations

IN (7)