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Gemcitabine with the standard dose (1000 mg/m2) is equal to low dose (250 mg/m2) with just prolongation of the infusion time in Patients with Advanced Pancreatic cancer

Randomized Phase II Study Comparing the Standard Protocol of Gemcitabine with Low Dose Gemcitabine over 6 Hours in Patients with Advanced Pancreatic Adenocarcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
PACTR
Registry ID
PACTR201901862142418
Enrollment
100
Registered
2019-01-16
Start date
2016-02-05
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

Gemcitabine

Sponsors

South Egypt cancer Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with advanced pancreatic cancer in males or females with age of 18 years or older, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, chemotherapy-naïve, and adequate hematologic, hepatic, and renal functions.

Exclusion criteria

Exclusion criteria: 1. Patient refuses to be enrolled in study. 2. Contraindication to gemcitabine 3. Concurrent anticancer or radiation therapy. ? Start of study therapy must be at 4 weeks after completion of previous anticancer therapy and 2 weeks from the date of last radiation. 4. Use of gemcitabine within the past 3 months with progression. 5. Any psychiatric illness/social situations that would limit compliance with study requirements. 6. Pregnant or nursing women. 7. Synchronous malignancies i.e associated other body cancers.

Design outcomes

Primary

MeasureTime frame
The primary end points were progression free survival (PFS), defined as the time from the start of treatment to disease progression or death from any cause, whichever came first, and safety through assessment toxicity profile based on CTCAE.

Secondary

MeasureTime frame
Secondary efficacy end points were overall survival (OS; defined as the time from the start of treatment to disease progression, death from any cause, or date of last follow up, whichever came first.), overall response rate (ORR; defined as sum of rates of complete response (CR) and partial response (PR) to chemotherapy), and disease control rate (DCR; defined as sum of rates of stable disease (SD), complete response, and partial response).

Countries

Egypt

Contacts

Public ContactMona Sayed

Assisstent Prof of clinical Oncology Prof

mmsaamz@yahoo.com01062049092

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026