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NCT Number: NCT00006389

Bryostatin 1 and Cisplatin in Treating Patients With Metastatic or Unresectable Stomach Cancer

Phase II trial to study the effectiveness of bryostatin 1 and cisplatin in treating patients who have metastatic or unresectable stomach cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bryostatin 1 may increase the effectiveness of cisplatin by making tumor cells more sensitive to the drug. Combining cisplatin with bryostatin 1 may kill more tumor cells.

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Key information

Conditions

Stage III Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stage IV Gastric Cancer Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Southern California

Los Angeles, California, 90033-0804, United States

About this study

OBJECTIVES:

I. Determine the response rate and survival in patients with metastatic or unresectable carcinoma of the stomach treated with bryostatin 1 and cisplatin.

II. Determine the toxic effects of this regimen in these patients. III. Determine the molecular determinants of response to this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of metastatic or unresectable carcinoma of the stomach
  • Measurable disease
  • No brain metastasis
  • Performance status - Karnofsky 70-100%
  • More than 3 months
  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL
  • No history of any bleeding disorders
  • Bilirubin no greater than 1.5 mg/dL
  • Transaminases no greater than 2 times normal
  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min
  • No history of peptic ulceration or gastrointestinal bleeding
  • No active infection
  • No seizure disorder
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No other serious concurrent illness that would preclude study entry
  • No medical, social, or psychological factors that would preclude study entry
  • No prior chemotherapy
  • No prior radiotherapy
  • More than 4 weeks since prior major surgery
  • Prior incomplete resection allowed
  • No other prior antitumor treatment

Treatment and study plan

bryostatin 1

Drug

Given IV

Other names: B705008K112, BRYO, Bryostatin

Cisplatin

Drug

Given IV

Other names: CACP, CDDP, CPDD, DDP

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Observed Response Rate.

    Time frame: Best response recorded from the start of treatment until disease progression/recurrence. Assessed every 2 cycles.

    All patients had measurable disease and were assessed after 2 cycles of chemotherapy by medical photograph, plain x-ray, CT, MRI or other imaging scans of at least 2.0 cm or greater with conventional techniques or 1.0 cm or greater with spiral CT. Patients were evaluated by RECIST criteria. All measurable lesions, up to 10 "target lesions" were recorded and measured at baseline across the longest diameter (LD). All other non-target lesions were documented as present or absent. Complete Response (CR) was defined as complete disappearance of the tumor, partial response (PR) was defined as at least a 30% decrease of the sum of the LD of the target lesions, using the baseline sum LD as the reference

    The observed response rate was defined as the percentage of evaluable patients whose best response is a CR or PR with associated 95% confidence interval.

Secondary outcomes

  1. Overall Survival

    Time frame: 18 months

    Overall survival was estimated according to the Kaplan-Meier product-limit method.

  2. Progression-free Survival

    Time frame: 18 months

    Progression-free survival was estimated according to the Kaplan-Meier product-limit method

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

A Phase II Combination Trial of Bryostatin-1 and Cisplatin in the Treatment of Metastatic Gastric Cancer

Important dates

Study start
2000
Primary completion
2010
Study completion
2010
First posted
Jan 27, 2003
Registry last updated
Oct 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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