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Effectiveness and Safety Study of Pegamotecan (PEG-Camptothecin) in Patients With Locally Advanced or Metastatic Cancer of the Stomach or Gastroesophageal Junction Who Have Relapsed or Progressed Following a Previous Chemotherapy Treatment


Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer of Stomach, Gastroesophageal Cancer

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Trial Information

Effectiveness and Safety Study of Pegamotecan (PEG-Camptothecin) in Patients With Locally Advanced or Metastatic Cancer of the Stomach or Gastroesophageal Junction Who Have Relapsed or Progressed Following a Previous Chemotherapy Treatment


Inclusion Criteria:



- Pathologically confirmed diagnosis of adenocarcinoma of the stomach or
gastroesophageal junction.

- Disease measurable in at least one dimension.

- Target tumors outside of prior radiation field(s).

- An Eastern Cooperative Oncology Group (ECOG) performance scale score of 0 or 1

- Adequate hematologic profile, as determined by hemoglobin, platelet, and neutrophil
count.

- Adequate renal function, as determined by serum creatinine and serum albumin
measurements.

- Adequate liver function, as determined by total bilirubin and transaminases levels.
Transaminases may be <= 5.0x ULN if due to metastatic disease in the liver.

- Fully recovered from prior surgery.

- No history of hemorrhagic cystitis.

- No microscopic hematuria (>10 RBC/hpf) unless documented to be due to an infection or
non-bladder origin.

- Capable of understanding the protocol requirements and risks and providing written
informed consent.

Exclusion Criteria:

- Concurrent serious medical illness unrelated to tumor within the past 6 months.

- Known chronic infectious disease, such as AIDS or hepatitis (screening for hepatitis
and HIV will not be performed).

- Positive screening pregnancy test or is breast-feeding.

- Female or male subject of reproductive capacity who is unwilling to use methods
appropriate to prevent pregnancy during the course of this study.

- Receiving concurrent chemotherapy, investigational agents, radiotherapy, surgery, or
has received wide field radiation within the previous 4 weeks.

- History of another malignancy (except basal and squamous cell carcinomas of the skin
and carcinoma in situ of the cervix) within the last 5 years.

- Known or clinically suspected brain metastases.

- Received more than one prior regimen of chemotherapy for locally advanced or
metastatic adenocarcinoma of the stomach or GE junction.

- Received prior neoadjuvant and/or adjuvant cytotoxic chemotherapy

- Received any investigational drug within the last 30 days.

- Not fully recovered from any prior, and from any reversible side effects related to
the administration of cytotoxic chemotherapy, investigational agents, or radiation
therapy.

- Prior treatment with a camptothecin analog.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

CAM-9011

NCT ID:

NCT00080002

Start Date:

December 2003

Completion Date:

Related Keywords:

  • Cancer of Stomach
  • Gastroesophageal Cancer
  • cancer
  • gastric
  • gastroesophageal junction
  • neoplasms
  • gastric cancer
  • gastric neoplasms
  • Stomach Neoplasms
  • Neoplasm Metastasis

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